Contact-type patch, staining method using the same, and manufacturing method thereof

ABSTRACT

The present disclosure relates to a gel-phase patch that performs a function of assisting in staining during a staining process such as a process of coming into contact with a specimen such as blood to perform a staining function of staining the specimen, a process of fixing the specimen, or a process of forming an optimal pH at a specimen stained by a staining sample. According to an aspect of the present disclosure, a contact-type staining patch includes a staining solution that reacts with a specimen and a gel receptor provided as a gel matrix of a mesh structure in which a pore that accommodates the staining solution is formed and the mesh structure prevents the staining solution in the pore from leaking or degenerating, and having a contact surface that comes into contact with the specimen to transfer some of the staining solution to the specimen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/455,484 filed Jun. 27, 2019, which is a divisional of U.S. patentapplication Ser. No. 15/206,247, filed Jul. 9, 2016, now U.S. Pat. No.10,371,610, which claims priority to and the benefit of U.S. ProvisionalPatent Application No. 62/298,959, filed Feb. 23, 2016 and Korean PatentApplication Nos. 10-2016-0069936, 10-2016-0069937, and 10-2016-0069938filed Jun. 4, 2016, the disclosure of each of which is incorporated byreference herein in its entirety.

BACKGROUND 1. Field of the Invention

The present disclosure relates to a contact-type patch, a stainingmethod using the same, and a manufacturing method thereof, and moreparticularly, to a gel-phase patch that performs a function of assistingin staining during a staining process by coming into contact with aspecimen such as blood to perform a staining function of staining thespecimen, fixing a specimen, or forming an optimal pH at a specimenstained by a staining sample, a staining method using the same, and amanufacturing method thereof.

2. Discussion of Related Art

A blood smear examination is a testing method in which blood is smearedand stained and morphologies of blood cells are observed using amicroscope. A blood smear examination is mostly used in testing forinfections of parasitic diseases such as malaria, blood cancersincluding leukemia, or congenital abnormalities in blood cellmorphology.

A rapid diagnostic test (RDT) and a blood smear examination are mostlyused in tests for parasitic diseases such as malaria. In the case of theRDT, there is an advantage in which a convenient, prompt test isperformed using a relatively low-cost diagnostic kit, but there is aproblem in that a test result is quite inaccurate. Consequently,nowadays, a blood smear examination is recommended for a more accuratetest.

A blood smear examination is a method of testing for a disease byinjecting a patient's blood in a slide, smearing and staining the blood,and observing the stained blood using a microscope. Since a processes ofsmearing or staining blood and observing it with a microscope depends onmanual work of a tester in a conventional blood smear examination, thereis a problem in that it is difficult to smoothly carry out the testsince a state of the smeared blood is not uniform or blood iserroneously stained due to an error of a reaction condition in astaining process when a tester is unskilled. Accordingly, it is actuallydifficult to apply a blood smear examination to a test for a disease inunderdeveloped countries such as some countries in Africa which lackmedical personnel.

SUMMARY OF THE INVENTION

An aspect of the present disclosure is to provide a gel-phasecontact-type staining patch that comes into contact with a specimen tostain the specimen.

Another aspect of the present disclosure is to provide a contact-typestaining patch that is manufactured in advance to be used any time.

Yet another aspect of the present disclosure is to provide acontact-type staining patch that can be used several times.

Still another aspect of the present disclosure is to provide acontact-type staining patch that can be conveniently used by omitting orsimplifying steps such as preprocessing (fixing) or postprocessing(washing and drying) during a staining process.

Still another aspect of the present disclosure is to provide acontact-type staining supplementary patch that performs various actionsto assist in staining during a staining process.

Still another aspect of the present disclosure is to provide acontact-type staining supplementary patch that provides a bufferingsolution to a specimen that has received a staining sample during astaining process.

Still another aspect of the present disclosure is to provide acontact-type staining supplementary patch that performs a specimenfixing function, a mordanting function, a decolorizing function, etc.during a staining process.

Aspects of the present disclosure are not limited to those mentionedabove, and unmentioned aspects will be clearly understood by those ofordinary skill in the art to which the present disclosure pertains fromthe present specification and the accompanying drawings.

According to an aspect of the present disclosure, there is provided acontact-type staining patch including a staining solution that reactswith a specimen and a gel receptor provided as a gel matrix of a meshstructure in which a pore that accommodates the staining solution isformed and the mesh structure prevents the staining solution in the porefrom leaking or degenerating, and having a contact surface that comesinto contact with the specimen to transfer some of the staining solutionto the specimen.

According to another aspect of the present disclosure, there is provideda contact-type staining patch including a gel receptor provided as a gelmatrix of a mesh structure in which a pore is formed and in which anyone surface is a contact surface that comes into contact with aspecimen; and a staining solution accommodated in the pore andconfigured to include a staining sample that reacts with the specimenand a buffering solution having a predetermined pH value to form anoptimal pH when a reaction occurs between the specimen and the stainingsample, wherein the mesh structure inhibits a leakage to an outside orcontamination of the staining solution and stores the staining solutionin the gel receptor while maintaining the predetermined pH value of thestaining solution, and, when the contact surface comes into contact withthe specimen, allows some of the staining solution to move to thespecimen and stain the specimen.

According to yet another aspect of the present disclosure, there isprovided a contact-type staining patch including a staining solutionthat includes a first staining sample that stains a specimen and asecond staining sample that stains the specimen and is different fromthe first staining sample; and a gel receptor provided as a gel matrixthat forms a pore configured to accommodate the staining solution andstore the staining solution accommodated in the pore, and configured tocome into contact with the specimen to transfer the first stainingsample and the second staining sample to the specimen.

According to still another aspect of the present disclosure, there isprovided a method of staining a specimen using a contact-type stainingpatch that includes a staining solution configured to react with thespecimen, and a gel receptor provided as a gel matrix of a meshstructure in which a pore that accommodates the staining solution isformed and the mesh structure prevents the staining solution in the porefrom leaking or degenerating, and having a contact surface that comesinto contact with the specimen to transfer some of the staining solutionto the specimen, the method comprising: preparing the contact-typestaining patch; contacting the specimen with the contact surface of thecontact-type staining patch; and staining the specimen by thecontact-type staining patch.

According to still another aspect of the present disclosure, there isprovided a contact-type staining patch that directly comes into contactwith a specimen to stain the specimen, the contact-type staining patchcomprising: a gel receptor having a predetermined concentration of agelable powder mixed with an aqueous solution; and a staining samplecontained in the gel receptor and configured to move from the gelreceptor to the specimen to stain the specimen when contact occursbetween the gel receptor and the specimen.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type staining patchprovided with a gel receptor that accommodates a staining sample in apore formed therein, prevents, by a mesh structure, the staining samplefrom leaking or being contaminated, and transfers the staining sample tothe specimen to stain the specimen when in contact with the specimen,the method comprising: mixing an aqueous solution, a gelable powder, andthe staining sample; boiling the mixture mixed in the mixing; andcooling the mixture to a gel phase.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type staining patchprovided with a gel receptor that accommodates a staining sample in apore formed therein, prevents, by a mesh structure, the staining samplefrom leaking or being contaminated, and transfers the staining sample tothe specimen to stain the specimen when in contact with the specimen,the method comprising: mixing a buffering solution that forms an optimalpH at the specimen when in contact with the specimen with a gelablepowder; heating the mixture of the buffering solution and the gelablepowder; and stirring and cooling the mixture to transition the mixtureto a gel phase, wherein, during the transition, the staining sample in aform of a solution is administered into the mixture.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type staining patchprovided with a gel receptor that accommodates a staining sample in apore formed therein, prevents, by a mesh structure, the staining samplefrom leaking or being contaminated, and transfers the staining sample tothe specimen to stain the specimen when in contact with the specimen,the method comprising: mixing a buffering solution that forms an optimalpH at the specimen when in contact with the specimen with a gelablepowder; heating the mixture of the buffering solution and the gelablepowder; cooling the mixture to transition the mixture to a gel phase;and absorbing the staining sample into the gel phase substance.

According to still another aspect of the present disclosure, there isprovided a contact-type buffering patch configured to come into contactwith a stained specimen to form an optimal pH at the specimen, thecontact-type buffering patch comprising: a buffering solution having apredetermined pH value related to an optimal pH of a staining sample;and a gel receptor configured to accommodate the buffering solution.

According to still another aspect of the present disclosure, there isprovided a contact-type fixating patch configured to come into contactwith a specimen placed on a slide to fix the specimen to the slide, thecontact-type fixating patch comprising: a specimen fixating agentconfigured to fix the specimen onto the slide; and a gel receptorconfigured to accommodate the fixating agent.

According to still another aspect of the present disclosure, there isprovided a contact-type decolorizing patch configured to come intocontact with a stained specimen to decolorize the specimen, thecontact-type decolorizing patch comprising: a decolorizing agentconfigured to remove a staining sample that has stained the specimenfrom the specimen to decolorize the specimen; and a gel receptorconfigured to accommodate the decolorizing agent.

According to still another aspect of the present disclosure, there isprovided a contact-type mordanting patch configured to come into contactwith a stained specimen to mordant the specimen, the contact-typemordanting patch comprising: a mordanting agent configured to react witha staining sample that has stained the specimen so the staining sampleforms a color; and a gel receptor configured to accommodate themordanting agent.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type buffering patch thatcomes into contact with a stained specimen to form an optimal pH of astaining sample that has stained the specimen, the method comprising:mixing a buffering solution having a predetermined pH value related tothe optimal pH of the staining sample; heating the mixture mixed in themixing; and cooling the mixture to a gel phase.

According to still another aspect of the present disclosure, there isprovided a staining method comprising: staining a specimen using astaining sample by contacting the specimen with a gel-phase stainingpatch that accommodates the staining sample; and forming an optimal pHof the staining sample at the specimen by contacting the specimen with agel-phase buffering patch that accommodates a buffering solution havinga predetermined pH value related to the optimal pH of the stainingsample.

According to still another aspect of the present disclosure, there isprovided a staining method using a dye that includes a first stainingsample and a second staining sample, the staining method comprising:staining a specimen with the first staining sample by contacting thespecimen with a gel-phase first staining patch that accommodates thefirst staining sample; staining the specimen with the second stainingsample by contacting the specimen with a gel-phase second staining patchthat accommodates the second staining sample; and creating an optimal pHof the dye at the specimen by contacting the specimen with a gel-phasebuffering patch that accommodates a buffering solution having apredetermined pH value related to an optimal pH of the dye.

Solutions of the present disclosure are not limited to those mentionedabove, and unmentioned solutions should be clearly understood by thoseof ordinary skill in the art to which the present disclosure pertainsfrom the present specification and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee

The above and other objects, features and advantages of the presentinvention will become more apparent to those of ordinary skill in theart by describing exemplary embodiments thereof in detail with referenceto the accompanying drawings, in which:

FIG. 1 is a cross-sectional view of a contact-type staining patchaccording to an embodiment of the present disclosure;

FIG. 2 is a view illustrating a conventional blood smear examinationprocess;

FIG. 3 is a view related to a process of preparing a staining solutionand a staining process of the conventional blood smear examinationprocess.

FIG. 4 is a perspective view of the contact-type staining patchaccording to an embodiment of the present disclosure;

FIG. 5 is a view illustrating a contact state between the contact-typestaining patch and a specimen slide according to an embodiment of thepresent disclosure;

FIG. 6 is a view related to a staining process using the contact-typestaining patch according to an embodiment of the present disclosure;

FIG. 7 is an image of a result of staining using a standard Giemsa stainprocess, i.e. a Giemsa staining technique, according to a conventionalfluid spraying means;

FIG. 8 shows images of results of staining using the Giemsa stainingtechnique according to a standard Giemsa stain process for each pHconcentration;

FIG. 9 is an image of a result of staining using the Giemsa stainingtechnique in which the contact-type staining patch according to anembodiment of the present disclosure is applied;

FIG. 10 is an image of another result of staining using the Giemsastaining technique in which the contact-type staining patch according toan embodiment of the present disclosure is applied;

FIG. 11 is a view illustrating results according to a standard stainingtechnique and a staining technique in which the contact-type stainingpatch is applied with respect to a Wright staining technique;

FIG. 12 is a view illustrating a result according to a stainingtechnique in which the contact-type staining patch is applied withrespect to a 4,6-diamidino-2-phenylindole (DAPI) staining technique;

FIG. 13 is a view illustrating a staining result observed before abuffering patch is brought into contact with blood after a methyleneblue patch and an eosin patch are brought into contact with the blood;

FIG. 14 is a view illustrating a staining result observed after thebuffering patch is brought into contact with blood after the methyleneblue patch and the eosin patch are brought into contact with the blood;

FIG. 15 is an exploded perspective view of an example of a test kitaccording to an embodiment of the present disclosure;

FIG. 16 is a coupled perspective view of the example of the test kitaccording to an embodiment of the present disclosure;

FIG. 17 is a perspective view of an example of a patch plate accordingto an embodiment of the present disclosure;

FIG. 18 is a cross-sectional view of an example of a storage unit in agroove form according to an embodiment of the present disclosure;

FIGS. 19 and 20 are cross-sectional views of the storage unit in agroove form having various contact guide means according to anembodiment of the present disclosure;

FIG. 21 is a perspective view of an example of a specimen plateaccording to an embodiment of the present disclosure;

FIG. 22 is a perspective view of an example of a specimen plate with astep between a specimen area and a non-specimen area according to anembodiment of the present disclosure;

FIG. 23 is a view illustrating a blood smearing means according to theconventional blood smear examination process;

FIG. 24 is a cross-sectional view of a smearing unit of the test kitaccording to an embodiment of the present disclosure;

FIG. 25 is a view illustrating a blood smearing process using thesmearing unit of the test kit according to the embodiment of the presentdisclosure;

FIG. 26 is a view illustrating a loading unit of the test kit accordingto an embodiment of the present disclosure;

FIG. 27 is a view related to loading of a specimen using the loadingunit according to an embodiment of the present disclosure;

FIG. 28 is a perspective view of a patch plate having a lifting guideaccording to an embodiment of the present disclosure; and

FIG. 29 is a perspective view of the specimen plate having the liftingguide according to an embodiment of the present disclosure.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Since embodiments described herein are for clearly describing the spiritof the present disclosure to those of ordinary skill in the art to whichthe present disclosure pertains, the present disclosure is not limitedto the embodiments described herein, and the scope of the presentdisclosure should be construed as including revised examples or modifiedexamples not departing from the spirit of the present disclosure.

General terms currently being used as widely as possible have beenselected as terms used herein in consideration of functions in thepresent disclosure, but the terms may be changed according to intentionsand practices of those of ordinary skill in the art to which the presentdisclosure pertains or the advent of new technologies, etc. However,unlike the above, when a particular term is defined as a certain meaningand used, the meaning of the term will be separately described.Consequently, the terms used herein should be construed based onsubstantial meanings of the terms and content throughout the presentspecification instead of simply based on names of the terms.

The accompanying drawings herein are for easily describing the presentdisclosure. Since shapes illustrated in the drawings may have beenexaggerated and displayed as needed to assist in understating thepresent disclosure, the present disclosure is not limited by thedrawings.

When detailed description of a known configuration or function relatedto the present disclosure is deemed to blur the gist of the presentdisclosure in the present specification, the detailed descriptionrelated thereto will be omitted as needed.

According to an aspect of the present disclosure, there is provided acontact-type staining patch including a staining solution that reactswith a specimen and a gel receptor provided as a gel matrix of a meshstructure in which a pore that accommodates the staining solution isformed and the mesh structure prevents the staining solution in the porefrom leaking or degenerating, and having a contact surface that comesinto contact with the specimen to transfer some of the staining solutionto the specimen.

Herein, the staining solution includes a staining sample configured toreact with the specimen and a solvent configured to create a reactioncondition of the staining sample; and the gel receptor uses the meshstructure to maintain a reaction condition of the staining solution.

Herein, in a process in which the staining solution is transferred tothe specimen through the contact surface, the gel receptor inhibitsexcessive movement of the staining solution by using the mesh structureto prevent residue from remaining at the specimen.

Herein, the contact-type staining patch is a staining patch configuredto assign a color to a specific component of the specimen, an antibodypatch including an antibody that causes an antigen-antibody reactionwith the specimen, or a DNA patch including a DNA probe that couples toa specific DNA sequence of the specimen.

Herein, the staining solution includes a detection inducing substanceselected from a staining substance that directly stains the specimen, aprecipitation/aggregation inducing substance that either precipitates oraggregates the specimen, a fluorescent substance that allows thespecimen to form a fluorescent color, an isotope that allows thespecimen to be detected with radiation, and an enzyme attached to thespecimen which secretes a detectable substance.

Herein, the staining solution includes an attaching substance that iscoupled to the detection inducing substance and reacts with a specificcomponent of the specimen to be attached to the specimen; and theattaching substance includes an antibody that causes an antigen-antibodyreaction with the specimen or a DNA probe that has a sequencecomplementary to a specific DNA sequence of the specimen.

Herein, the staining solution is provided in a liquid state; and the gelreceptor is provided as hydrogel that inhibits a leakage of the stainingsolution in the liquid state to the outside.

According to another aspect of the present disclosure, there is provideda contact-type staining patch including a gel receptor provided as a gelmatrix of a mesh structure in which a pore is formed and in which anyone surface is a contact surface that comes into contact with aspecimen; and a staining solution accommodated in the pore andconfigured to include a staining sample that reacts with the specimenand a buffering solution having a predetermined pH value to form anoptimal pH when a reaction occurs between the specimen and the stainingsample, wherein the mesh structure inhibits a leakage to an outside orcontamination of the staining solution and stores the staining solutionin the gel receptor while maintaining the predetermined pH value of thestaining solution, and, when the contact surface comes into contact withthe specimen, allows some of the staining solution to move to thespecimen and stain the specimen.

Herein, the predetermined pH value is the optimal pH or a pH that has adifference of a pH compensation value from the optimal pH.

Herein, a size of the predetermined pH value is within a pH range of 0.1to 0.4.

Herein, the pH compensation value is determined according to at leastone of a hardness and porosity of the gel receptor, a density of themesh structure, and a gel concentration of the gel receptor.

Herein, the pH compensation value increases as the gel receptor isharder, increases as the porosity is smaller, increases as the densityis higher, and increases as the gel concentration increases.

According to yet another aspect of the present disclosure, there isprovided a contact-type staining patch including a staining solutionthat includes a first staining sample that stains a specimen and asecond staining sample that stains the specimen and is different fromthe first staining sample; and a gel receptor provided as a gel matrixthat forms a pore configured to accommodate the staining solution andstore the staining solution accommodated in the pore, and configured tocome into contact with the specimen to transfer the first stainingsample and the second staining sample to the specimen.

According to still another aspect of the present disclosure, there isprovided a method of staining a specimen using a contact-type stainingpatch that includes a staining solution configured to react with thespecimen, and a gel receptor provided as a gel matrix of a meshstructure in which a pore that accommodates the staining solution isformed and the mesh structure prevents the staining solution in the porefrom leaking or degenerating, and having a contact surface that comesinto contact with the specimen to transfer some of the staining solutionto the specimen, the method comprising: preparing the contact-typestaining patch; contacting the specimen with the contact surface of thecontact-type staining patch; and staining the specimen by thecontact-type staining patch.

Herein, in the staining, the gel receptor maintains the stainingsolution in a state in which a reaction condition of the specimen issatisfied.

Herein, the method further comprises, after the staining, omittingprocesses of washing and drying the specimen and observing the stainedspecimen.

According to still another aspect of the present disclosure, there isprovided a contact-type staining patch that directly comes into contactwith a specimen to stain the specimen, the contact-type staining patchcomprising: a gel receptor having a predetermined concentration of agelable powder mixed with an aqueous solution; and a staining samplecontained in the gel receptor and configured to move from the gelreceptor to the specimen to stain the specimen when contact occursbetween the gel receptor and the specimen.

Herein, the gel receptor is hydrogel.

Herein, the powder is an agar or agarose powder.

Herein, the gel receptor is an agarose gel having a concentration of 1to 4%.

Herein, the patch further comprises at least one of an antiseptic, anantibiotic, and an evaporation preventing agent, wherein the antiseptic,the antibiotic, and the evaporation preventing agent are accommodated inthe pore.

Herein, the staining sample is a Romanowsky staining solution.

Herein, the aqueous solution is a buffering solution that forms anoptimal pH at the specimen when in contact with the specimen.

Herein, the buffering solution has a pH range of 6.8 to 7.4.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type staining patchprovided with a gel receptor that accommodates a staining sample in apore formed therein, prevents, by a mesh structure, the staining samplefrom leaking or being contaminated, and transfers the staining sample tothe specimen to stain the specimen when in contact with the specimen,the method comprising: mixing an aqueous solution, a gelable powder, andthe staining sample; boiling the mixture mixed in the mixing; andcooling the mixture to a gel phase.

Herein, the staining sample includes at least one of Giemsa powder,Wright powder, Giemsa-Wright powder, methylene blue, eosin, and Azure11.

Herein, the aqueous solution is a buffering solution that forms anoptimal pH at the specimen when in contact with the specimen.

Herein, the powder is an agar or agarose powder.

Herein, the gel phase has an agarose gel phase concentration of 1 to 4%.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type staining patchprovided with a gel receptor that accommodates a staining sample in apore formed therein, prevents, by a mesh structure, the staining samplefrom leaking or being contaminated, and transfers the staining sample tothe specimen to stain the specimen when in contact with the specimen,the method comprising: mixing a buffering solution that forms an optimalpH at the specimen when in contact with the specimen with a gelablepowder; heating the mixture of the buffering solution and the gelablepowder; and stirring and cooling the mixture to transition the mixtureto a gel phase, wherein, during the transition, the staining sample in aform of a solution is administered into the mixture.

Herein, the heating is performed by baking using a microwave.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type staining patchprovided with a gel receptor that accommodates a staining sample in apore formed therein, prevents, by a mesh structure, the staining samplefrom leaking or being contaminated, and transfers the staining sample tothe specimen to stain the specimen when in contact with the specimen,the method comprising: mixing a buffering solution that forms an optimalpH at the specimen when in contact with the specimen with a gelablepowder; heating the mixture of the buffering solution and the gelablepowder; cooling the mixture to transition the mixture to a gel phase;and absorbing the staining sample into the gel phase substance.

Herein, in the absorbing, the gel phase substance is injected into acontainer that accommodates the staining sample.

According to still another aspect of the present disclosure, there isprovided a contact-type buffering patch configured to come into contactwith a stained specimen to form an optimal pH at the specimen, thecontact-type buffering patch comprising: a buffering solution having apredetermined pH value related to an optimal pH of a staining sample;and a gel receptor configured to accommodate the buffering solution.

Herein, the gel receptor has a contact surface that comes into contactwith the specimen, and, when the contact surface is in contact with thespecimen, an optimal pH related to staining is created at the specimento cause a reaction between the specimen and the staining sample.

Herein, the predetermined pH value is identical to an optimal pH valueof the reaction.

Herein, the predetermined pH value is smaller than the optimal pH whenthe optimal pH is acidic and is larger than the optimal pH when theoptimal pH is basic.

Herein, a difference between the predetermined pH value and the optimalpH is determined according to at least one of a hardness of the gelreceptor, a porosity of the gel receptor, a gel concentration of the gelreceptor, and a density of a mesh structure of the gel receptor.

Herein, the gel receptor is hydrogel.

Herein, the hydrogel is an agarose gel.

Herein, the gel receptor has an agarose concentration of 1 to 3%.

Herein, the gel receptor has a mesh structure in which a pore thataccommodates the buffering solution therein is formed, and leakage to anoutside or degeneration of the buffering solution is prevented by themesh structure.

Herein, the gel receptor has a mesh structure in which a pore thataccommodates the buffering solution therein is formed, and controlstransfer of the buffering solution to the specimen to inhibit residuefrom remaining at the specimen when contact occurs between the specimenand the buffering solution.

Herein, the staining sample is a Romanowsky staining solution; and thebuffering solution has a pH of 6.6 to 7.6.

According to still another aspect of the present disclosure, there isprovided a contact-type fixating patch configured to come into contactwith a specimen placed on a slide to fix the specimen to the slide, thecontact-type fixating patch comprising: a specimen fixating agentconfigured to fix the specimen onto the slide; and a gel receptorconfigured to accommodate the fixating agent.

Herein, the fixating agent is alcohol.

Herein, the gel receptor is a non-hydrogel.

According to still another aspect of the present disclosure, there isprovided a contact-type decolorizing patch configured to come intocontact with a stained specimen to decolorize the specimen, thecontact-type decolorizing patch comprising: a decolorizing agentconfigured to remove a staining sample that has stained the specimenfrom the specimen to decolorize the specimen; and a gel receptorconfigured to accommodate the decolorizing agent.

According to still another aspect of the present disclosure, there isprovided a contact-type mordanting patch configured to come into contactwith a stained specimen to mordant the specimen, the contact-typemordanting patch comprising: a mordanting agent configured to react witha staining sample that has stained the specimen so the staining sampleforms a color; and a gel receptor configured to accommodate themordanting agent.

According to still another aspect of the present disclosure, there isprovided a method of manufacturing a contact-type buffering patch thatcomes into contact with a stained specimen to form an optimal pH of astaining sample that has stained the specimen, the method comprising:mixing a buffering solution having a predetermined pH value related tothe optimal pH of the staining sample; heating the mixture mixed in themixing; and cooling the mixture to a gel phase.

According to still another aspect of the present disclosure, there isprovided a staining method comprising: staining a specimen using astaining sample by contacting the specimen with a gel-phase stainingpatch that accommodates the staining sample; and forming an optimal pHof the staining sample at the specimen by contacting the specimen with agel-phase buffering patch that accommodates a buffering solution havinga predetermined pH value related to the optimal pH of the stainingsample.

According to still another aspect of the present disclosure, there isprovided a staining method using a dye that includes a first stainingsample and a second staining sample, the staining method comprising:staining a specimen with the first staining sample by contacting thespecimen with a gel-phase first staining patch that accommodates thefirst staining sample; staining the specimen with the second stainingsample by contacting the specimen with a gel-phase second staining patchthat accommodates the second staining sample; and creating an optimal pHof the dye at the specimen by contacting the specimen with a gel-phasebuffering patch that accommodates a buffering solution having apredetermined pH value related to an optimal pH of the dye.

Herein, the creating of the optimal pH of the dye at the specimen isperformed at one or more times of a first time between the staining withthe first staining sample and the staining with the second stainingsample and a second time after the staining with the second stainingsample.

Herein, in the creating of the optimal pH of the dye at the specimen,the buffering patch absorbs some of the first staining sample thatreacts with the specimen first to induce a reaction between the secondstaining sample and the specimen.

1. Contact-Type Staining Patch

1.1 Gel-Phase Contact-Type Staining Patch

Hereinafter, a contact-type staining patch 100 according to anembodiment of the present disclosure will be described.

The contact-type staining patch 100 according to the embodiment of thepresent disclosure may come into contact with a specimen T and stain thespecimen T.

For example, the contact-type staining patch 100 may be used in variousways such as for 1) techniques in which an object to be stained isdirectly reacted with a staining sample 140 to be stained including 1-1)a Giemsa staining technique or a Wright staining technique isaccompanied by a blood smear examination including a peripheral bloodsmear examination used in an examination for malaria and 1-2) a simplestaining technique, a Gram staining technique, or an AFB [Ziehl-Neelsen]technique accompanied by a bacteriological examination 2) a Papanicolaousmear test mostly used in cervical cancer examination, 3) a fluorescencestaining technique such as 4,6-diamidino-2-phenylindole (DAPI), 4)techniques in which an antigen-antibody reaction is used and an objectto be detected using an antibody coupled to an isotope, a florescentsubstance, an enzyme, etc. may indirectly form color by radiationdetection, fluorescent color formation, and enzymes including 4-1) animmunohistochemistry technique which is a special staining techniqueused in screening for cancer or 4-2) an enzyme linked immunosorbentassay (ELISA) technique used in a human immunodeficiency virus (HIV)test, 5) a fluorescence in situ hybridization (FISH) technique in which,to check a specific DNA sequence, a fluorescent substance is coupled toa DNA probe complementary to a target sequence to detect the targetsequence, and 6) a precipitation technique or a cohesion technique usingan antigen-antibody reaction.

In the present disclosure, “staining” in the contact-type staining patch100 is not to be construed as limited to directly staining an object tobe detected from the specimen T, but should be construed as a term thatcomprehensively encompasses all methods in which a specific targetsubstance may be detected and checked for in the specimen T such as amethod in which an object to be detected can form a fluorescent color, amethod in which radiation can be detected, a method in which the objectto be detected can react and form color when injected in a specificsubstrate by an enzyme, and a method in which cohesion or precipitationis induced so that the object to be detected can be detected.

In other words, in the present disclosure, the contact-type stainingpatch 100 serves to make a substance to be tested be in a statedetectable in the specimen T, and thus, according to the actualtechnical spirit thereof, a contact-type “detection inducing” patchwould be a more clear expression. However, to assist in convenience ofdescribing and understanding the present disclosure, the term,contact-type “staining” patch, will be used as a comprehensive meaningas needed.

Consequently, similar to above, it should be reasonable that the term,“stain” also be construed as having a wide meaning that encompasses alltypes of “detection inducing” that include inducing a fluorescent colorformation, a color formation, radiation detection, precipitation,cohesion of an object to be detected, and inducing the object to bedetected to be in other detectable states rather than being construed ashaving a narrow meaning of directly staining the object to be detected.

Meanwhile, along with the above, the specimen T refers to a substancethat is an object to be tested, and it should be reasonable that thespecimen T is construed as encompassing all biological samples that aresubject to medical tests such as blood, cells, tissues, chromosomes,DNA, parasites, bacteria, etc.

Staining of the specimen T using the contact-type staining patch 100 maybe performed as follows.

First, the contact-type staining patch 100 is provided in a gel phase,and the staining sample 140 is stored in a pore 122 therein. In thisstate, when the contact-type staining patch 100 is brought into contactwith the specimen T, the staining sample 140 in the pore 122 inside thecontact-type staining patch 100 passes through a mesh structure of a gelmatrix, moves to the specimen T, and stains a substance to be stained.

1.1.1. Basic Composition of a Contact-Type Staining Patch

FIG. 1 is a cross-sectional view of the contact-type staining patch 100according to an embodiment of the present disclosure.

Referring to FIG. 1, the contact-type staining patch 100 may include agel receptor 120 and the staining sample 140.

The gel receptor 120 is provided with a gel-phase substance having aporous mesh structure that forms the pore 122 therein. The pore 122 ofthe gel receptor 120 may accommodate the staining sample 140.

The gel receptor 120 may be provided with various types of gel that forma gel matrix. For example, the gel receptor 120 may be gel formed ofagarose. Here, agar may be used instead of agarose. When agar andagarose are compared to each other, the gel receptor 120 formed ofagarose, which is a result of refining a polygalactose component inagar, has an advantage in terms of transparency or hardness, but a casein which agar is used may have an advantage in terms of cost when massproduction is performed since a refining process and the like may beomitted.

Other than the above, a silicone gel, a silica gel, silicone rubber,polydimethylsiloxane (PDMS) known as a main component of a resin, apolymethylmethacrylate (PMMA) gel, and a gel using other variousmaterials may be used as the gel receptor 120.

Hydrogel that can hold the staining sample 140 which is usually in theform of an aqueous solution may be used as the gel receptor 120, but,unlike the above, a non-hydrogel substance may also be used as needed.

The staining sample 140 is a substance that reacts with the specimen Tto stain the specimen T. Here, the staining sample 140 should beconstrued as having a comprehensive meaning that encompasses allsubstances, not only staining reagents that directly stain the specimenT but also an antibody, a DNA probe, or the like to which a stainingsubstance, a fluorescent substance, or the like is coupled, that reactwith a substance to be stained to make the substance to be staineddetectable in examples of staining methods in which the contact-typestaining patch 100 described above can be used.

For example, the staining sample 140 may include various types ofstaining solutions such as those used in Romanowsky staining techniquesincluding acetocarmine, methylene blue, eosin, acid fuchsin, safranin,Janus Green B, hematoxylin, Giemsa solution, Wright solution,Wright-Giemsa solution, Leishman staining solution, Gram stainingsolution, carbol-fuchsin, and Ziehl-Neelsen solution.

As another example, the staining sample 140 may also include a DNA probecoupled to DAPI fluorochorme, a fluorescent substance, and an antibodycoupled to an enzyme, a fluorescent substance, an isotope, etc. Ofcourse, the staining sample 140 is not limited to the examples describedabove and may be any substance that reacts with a substance to bestained to make the substance to be stained detectable as mentionedabove.

One staining sample 140 or two or more staining samples 140 may be mixedand stored in the pore 122.

For example, when attempting to perform a simple stain (a method offixing bacteria and the like to a slide S and staining with one stainingsample 140) using the contact-type staining patch 100, the one stainingsample 140 may be stored in the pore 122. Here, methylene blue, crystalviolet, safranin, etc. may be used as the staining sample 140. Similarto this, when attempting to use the contact-type staining patch 100 todetect only a specific sequence, one staining sample 140 in which adetection inducing substance such as a fluorescent substance is coupledto one type of DNA probe corresponding to the specific sequence may beused.

Unlike the example above, when attempting to perform a Giemsa stainusing the contact-type staining patch 100, a composite sample formed ofa heterogeneous staining substance including eosin, which stainscytoplasm red, and methylene blue, which stains a nucleus violet, may beused as the staining sample 140. That is, a first staining sample 140-1which is eosin and a second staining sample 140-2 which is methyleneblue may be mixed and stored in the pore 122.

Of course, a plurality of contact-type staining patches 100 eachcontaining one staining sample 140 may also be used instead of mixingand storing a plurality of staining samples 140 in the pore 122 asdescribed above in a staining technique in which a composite sample isused as the staining sample 140. For example, when attempting to performa Giemsa stain, the staining samples 140 may also be separately storedin separate contact-type staining patches 100 like an eosin patch (afirst contact-type staining patch 100-1 that stores eosin as the firststaining sample 140-1) and a methylene blue patch (a second contact-typestaining patch 100-2 that stores methylene blue as the second stainingsample 140-2).

1.1.2 Buffering Solution of a Contact-Type Staining Patch

The staining sample 140 may be accommodated in the pore 122 of the gelreceptor 120 in a form that is dissolved in a solvent as needed. Here, abuffering solution B that creates a reaction condition when a reactionoccurs between the staining sample 140 and a substance to be stained maybe used as the solvent.

The buffering solution B serves to create a reaction environment inwhich a reaction between an object to be stained and the staining sample140 may occur during a staining reaction. For example, in a stainingreaction such as a Giemsa stain, since basic methylene blue couples to acell nucleus having a negative charge and stains the cell nucleus andacidic eosin stains a cytoplasm, pH concentrations are closely relatedto a staining result. Thus, creating proper pH concentrations may beextremely important for staining to be performed correctly.Consequently, in this case, the buffering solution B may be a pHbuffering solution that maintains an optimal pH with respect to areaction using the staining sample 140 of the contact-type stainingpatch 100.

Although it will also be described below in description related to abuffering patch, a solution with a pH concentration equal to an optimalpH of a staining reaction may be used as the buffering solution B.

Alternatively, a solution with a pH concentration slightly differentfrom the optimal pH of the staining reaction may be used as thebuffering solution B. Unlike a conventional staining process in which alarge amount of the buffering solution B is sprayed to the specimen Twhich is stained in a buffer step to set an optimal pH, the bufferingsolution B in the contact-type staining patch 100 is contained in thegel receptor 120, and the optimal pH of a staining reaction is setduring a process in which the contact-type staining patch 100 and thespecimen T come into contact with each other. Here, when the bufferingsolution B is contained in the gel receptor 120, the buffering solutionB may react with the staining sample 140 and the like and the pH of thebuffering solution B may be slightly adjusted. To give a concreteexample, in a case of the contact-type staining patch 100 that usesGiemsa dye as the staining sample 140, a pH of the buffering solution Brises slightly after manufacturing the contact-type staining patch 100in comparison to the pH of the buffering solution B before manufacturingthe contact-type staining patch 100. This is due to a factor caused byinteractions among the buffering solution B, the staining sample 140,and the gel receptor 120 and a fact that an actually acting pH changesslightly when a buffering action is performed in a gel contact-typeinstead of in a conventional liquid spray type. Again, with respect tothe contact-type staining patch 100 for a Giemsa stain, a pH of thebuffering solution B contained in the contact-type staining patch 100may be increased by approximately 0.1 to 0.4 in comparison to a pH of araw material buffering solution B. When a desired optimal pH of areaction is 6.8, a solution having a pH concentration of approximately6.4 to 6.7 may be used as the buffering solution B. Setting an optimalpH of the contact-type staining patch 100 using a pH of the bufferingsolution B will be more clearly described in a buffering patch partbelow.

Specifically, when the contact-type staining patch 100 for a Giemsastain manufactured using the buffering solution B having a pH ofapproximately 6.5 is brought into contact with the specimen T which isstained and the stained specimen T is observed, a staining resultsimilar to that resulting from spraying the buffering solution B havinga pH of approximately 6.6 to 6.9 onto the specimen T which is stainedwas actually observed.

In other words, an effective pH of the contact-type staining patch 100manufactured using the buffering solution B having a specific pH valuemay be changed to be slightly different from a pH value of the bufferingsolution B itself. Here, an effective pH refers to a pH acting during areaction between the specimen T and a patch and may be, for example, apH created at the specimen T when the buffering solution B in a liquidphase is sprayed onto the specimen T.

Consequently, when manufacturing the contact-type staining patch 100, apH of the buffering solution B has to be adjusted so that the effectivepH value of the contact-type staining patch 100 is substantially equalto an optimal pH value of a staining technique.

That is, a pH value of the buffering solution B itself which will beused in a buffering patch may be set as a value compensated for by a pHcompensation value in consideration of a pH biased due to interactionsamong a gel, a staining sample, and the buffering solution B in a gelmatrix with respect to an optimal pH value that facilitates stainingwhich may be defined in a conventional staining technique.

Here, the pH compensation value may be determined according to featuresof a gel, a type of a staining sample, an amount of a staining sample ora gel substance with respect to the buffering solution B, etc.

Here, with respect to features of a gel, a size (i.e., an absolutevalue) of the pH compensation value may be increased or decreasedaccording to a concentration, a hardness, porosity, density of a meshstructure, etc. of a gel of the gel receptor 120. For example, a size ofa pH compensation value may increase as a concentration of the gel ofthe gel receptor 120 increases, and a size of the pH compensation valuemay decrease as the concentration of the gel lowers. In addition, forexample, when an agarose gel is used as the gel receptor 120, a size ofthe pH compensation value may increase as a concentration of agaroseincreases, and a size of the pH compensation value may decrease as theconcentration of agarose lowers. In addition, a size of the pHcompensation value may increase as the gel receptor 120 hardens, and asize of the pH compensation value may decrease as the gel receptor 120softens. In addition, a size of the pH compensation value may decreaseas porosity of the gel receptor 120 increases, and a size of the pHcompensation value may increase as the porosity decreases. In addition,a size of the pH compensation value may increase as density of the meshstructure of the gel receptor 120 increases, and a size of the pHcompensation value may decrease as the density lowers.

In addition, with respect to interactions of a staining substance, alarger pH shift may occur as an amount of the staining substance withrespect to the buffering solution B increases, and whether it is shiftedtoward being acidic or basic may be determined according to a type ofthe staining substance. In a case of a Giemsa stain substance, a pHshift of approximately 0.1-0.4 toward being basic may occur with respectto a phosphate buffer saline (PBS) buffer. The pH shift may be larger asan amount of a staining substance with respect to the buffering solutionincreases, and a pH shift toward the basic direction may occur when atype of the staining substance changes.

In the contact-type staining patch 100 according to an embodiment of thepresent disclosure described above, the gel receptor 120 performs afunction of storing the staining sample 140. Here, storing refers to 1)the gel receptor 120 preventing the staining sample 140 stored thereinfrom leaking to the outside; and 2) preventing the staining sample 140from being contaminated by the outside. The storing function is basedon 1) a structural property of the gel matrix of the gel receptor 120;and 2) an electrochemical property of the gel receptor 120 and thestaining sample 140.

The storing function based on the structural feature of the gel receptor120 may be accomplished as the staining sample 140 accommodated in thepore 122 by the mesh structure of the gel receptor 120 is inhibited frommoving up to a surface of the gel receptor 120. This will be describedin detail as follows.

The gel receptor 120 may form the pore 122 in the mesh structure andaccommodate the staining sample 140 inside the gel receptor 120. Here,the staining sample 140 has to move up to the surface of the gelreceptor 120 from the pore 122 for the staining sample 140 inside thepore 122 to exit to the outside. In this process, since the stainingsample 140 has to pass through the mesh structure, the staining sample140 accommodated inside the pore 122 may be prevented from leaking tothe outside. In other words, the mesh structure of the gel receptor 120inhibits the staining sample 140 accommodated in the pore 122 fromevaporating or leaking through the surface of the gel receptor 120. Inaddition, for the staining sample 140 to be contaminated, a contaminantfrom the outside has to pass through the surface of the gel receptor 120and move up to the pore 122 inside the gel receptor 120. In thisprocess, the mesh structure of the gel receptor 120 may inhibit foreignsubstances from being introduced into the gel receptor 120 and preventthe staining sample 140 inside the gel receptor 120 from beingcontaminated.

In addition, the storing function based on the electrochemical propertyof the gel receptor 120 may be accomplished by electrochemicalreactivity between the gel receptor 120 and the staining sample 140. Forexample, when the staining sample 140 stored in the pore 122 of the gelreceptor 120 is in a form of an aqueous solution, a hydrophilic gel maybe prepared as the gel receptor 120 to inhibit the staining sample 140from leaking to the outside from the gel receptor 120. In addition,according to the property of the gel receptor 120, since a substancewith the opposite property cannot infiltrate into the gel receptor 120from the outside (for example, a hydrophobic contaminant is inhibitedfrom infiltrating into the hydrophilic gel receptor 120), the stainingsample 140 stored in the gel receptor 120 can be prevented from beingcontaminated.

In addition, the storing function of the gel receptor 120 is not limitedto simply preventing leakage or contamination of the staining sample140. A reaction condition in staining is extremely important to smoothlystain blood in a blood smear examination. For example, when a proper pHconcentration is not achieved, a reaction between the staining sample140 and blood may not occur properly, erroneously stained blood may beobserved with a microscope, and an error may occur in a test as aresult.

With respect to the above, in the present disclosure, the stainingsample 140 may be accommodated in the pore 122 of the gel receptor 120while having a proper reaction condition and the gel receptor 120 maystore the staining sample 140 while the reaction condition ismaintained. For example, a Giemsa stain is performed under a pH of 7.2.For this, the staining sample 140 for the Giemsa stain may be stored inthe form of an aqueous solution having a pH of 7.2 in the pore 122 ofthe gel receptor 120. Since leakage to the outside or contamination dueto an external substance of the staining sample 140 or the aqueoussolution is prevented by the mesh structure of the gel receptor 120, thestaining sample 140 for the Giemsa stain may be stored in the form of anaqueous solution whose pH is maintained at 7.2 inside the gel receptor120.

The contact-type staining patch 100 has an advantage of being able toprotect the staining sample 140 for a long period while maintaining adesired reaction condition. This is a great advantage over a case inwhich a conventional staining technique is used in which a reactioncondition needs to be set each time staining is conducted.

1.1.2 Additional Compositions of the Contact-Type Staining Patch

Meanwhile, the contact-type staining patch 100 may further includevarious additional compositions. Similar to the staining sample 140, theadditional compositions may be accommodated in the pore 122 of the gelreceptor 120 to be contained in the contact-type staining patch 100.

For example, an evaporation preventing agent may be included in thecontact-type staining patch 100. The evaporation preventing agent mayperform a role of preventing the staining sample 140 inside the gelreceptor 120 from leaking to the outside by evaporation. Although thestaining sample 140 stored in the pore 122 of the gel receptor 120 in aform of an aqueous solution and the like as described above is inhibitedto some extent from leaking to the outside by a water-soluble propertyof the gel matrix structure or the gel receptor 120, the staining sample140 may be stored for a long period while performance of thecontact-type staining patch 100 is maintained by the evaporationpreventing agent contained in the gel receptor 120. The evaporationpreventing agent may have a weight ratio of 5% or less and maypreferably have a weight ratio of 1% or less.

In another example, a degeneration preventing agent may be included inthe contact-type staining patch 100. Like an antiseptic and anantibiotic that prevents proliferation of bacteria in the contact-typestaining patch 100, the degeneration preventing agent performs afunction of preventing the staining sample 140 inside the contact-typestaining patch 100 from degenerating due to various causes. When the gelreceptor 120 is exposed, bacteria or germs may proliferate therein, andperformance of the contact-type staining patch 100 may be degraded as aresult due to contamination of the staining sample 140. When thedegeneration preventing agent is added to the contact-type stainingpatch 100, a shelf life of the contact-type staining patch 100 may beextended.

1.2. Staining Process Using the Contact-Type Staining Patch

FIG. 2 is a view illustrating a conventional blood smear examinationprocess, and FIG. 3 is a view related to a staining process of theconventional blood smear examination process.

Referring to FIG. 2, the conventional blood smear examination isconducted as follows. First, a reactant such as a staining solution isprepared. Next, blood is injected onto the slide S, and the blood issmeared. When the blood is smeared on the slide S, the blood is fixedand dried. The fixing of the smeared blood may be performed primarilyusing a chemical fixing means. When the smeared blood is fixed to theslide S, a staining solution is poured on it to stain the blood. Here,since the staining solution is poured onto the blood and thus a largeamount of the staining solution is mixed with the blood, the mixture ofthe staining solution and the blood is washed and then dried again.Through this process, the stained blood on the slide S may be observedusing a microscope and the like to conduct the blood smear examination.

Referring to FIG. 3, staining is performed in a form of spraying astaining solution onto the slide S on which blood is smeared in theconventional blood smear examination, and, for this, a staining solutionhas to be manufactured impromptu using a powdery staining sample 140.Consequently, manual work of a skilled person or separate equipment formixing a proper ratio is required to set a ratio between the stainingsample 140 and a solvent. Furthermore, when a staining solution wasmanufactured in advance, 1) the staining solution manufactured inadvance may contact air and react; 2) a reaction between the solvent andthe staining sample 140 may occur inside the staining solution; or 3) areaction between heterogeneous staining samples 140 may occur when thestaining solution is manufactured and used by mixing a plurality ofstaining samples 140. Accordingly, since the staining solution iscontaminated or a proper reaction condition cannot be maintained, thestaining solution can only be used for a few hours after manufacture.

With respect to this, since the contact-type staining patch 100according to an embodiment of the present disclosure stores the stainingsample 140 in the pore 122 therein that forms the mesh structure in thegel receptor 120 thereof while a desired reaction condition ismaintained, the contact-type staining patch 100 can be manufactured inadvance instead of manufacturing a staining solution at an examinationsite by mixing the staining sample 140 with a solvent, and thecontact-type staining patch 100 can be used in examinations over a longperiod.

FIG. 4 is a perspective view of the contact-type staining patch 100according to an embodiment of the present disclosure, and FIG. 5 is aview illustrating a contact state between the contact-type stainingpatch 100 and the slide S according to an embodiment of the presentdisclosure.

Referring to FIG. 4, a shape of the contact-type staining patch 100 maybe defined by a shape of the gel receptor 120 and may have a contactsurface 102 for coming into contact with the specimen T formed on atleast one surface thereof. Here, the contact surface 102 is a surfacethat directly comes into contact with the specimen T and may preferablybe a plane to easily come into contact with the specimen T smeared onthe slide S. For example, the contact-type staining patch 100 may beprovided in the form of a column as illustrated in FIG. 4, and in such acylindrical form, one of an upper surface and a lower surface of thecolumn may be the contact surface 102.

With reference to FIG. 5, it can be seen that the contact-type stainingpatch 100 is brought into contact with the specimen T by mounting theslide S on which the specimen T is smeared on the upper surface of thecontact-type staining patch 100 illustrated in FIG. 4 or, conversely, bymounting the contact-type staining patch 100 on the slide S on which thespecimen T is smeared.

Meanwhile, the shape of the contact-type staining patch 100 is notlimited to the shape illustrated in FIG. 4 and may also include aplurality of contact surfaces 102. For example, the contact-typestaining patch 100 may be manufactured in a hexahedral shape, and one ora plurality of surfaces thereof may be used as the contact surfaces 102.In another example, the contact-type staining patch 100 may also bemanufactured in a hemispherical shape in which a bottom surface thereofis the contact surface 102.

FIG. 6 is a view related to a staining process using the contact-typestaining patch 100 according to an embodiment of the present disclosure.

Referring to FIG. 6, the contact-type staining patch 100 may come intocontact with the specimen T smeared on the slide S. In other words, thecontact surface 102 of the gel receptor 120 may directly come intocontact with the specimen T. When the contact occurs, the stainingsample 140 passes through the mesh structure and moves to the specimen Tthrough the contact surface by an electrochemical action between aspecific component in the specimen T that reacts with the specimen T orthe staining sample 140 and the staining sample 140 stored inside thegel receptor 120, i.e., accommodated in the pore 122 therein. Thestaining sample 140 that has moved to the specimen T may react with thespecimen T or the specific component in the specimen T and stain thespecimen T.

Here, since the staining sample 140 is stored inside the gel receptor120 while the reaction condition is maintained, staining can be smoothlyperformed even though the reaction condition is not separately adjusted.

Meanwhile, although the staining sample 140 passes through the meshstructure of the gel receptor 120 and moves to the specimen T by a forceacting between the staining sample 140 and the specimen T or thespecific component in the specimen T, since the movement is performedwhile being somewhat limited by the mesh structure, an excessively largeamount of the staining sample 140 or the staining solution may beprevented from moving to the specimen T.

Here, the amount of the staining sample 140 or the staining solutionmoving to the specimen T may be controlled by adjusting a density of themesh structure and a degree of liquidity, porosity, etc. of gel. Thatis, by properly adjusting a hardness of the gel, only a proper amount ofthe staining sample 140 may be transferred to the specimen T from thecontact-type staining patch 100.

For example, when the contact-type staining patch 100 for a Giemsa stainis manufactured using an agarose gel for a peripheral blood smearexamination, the concentration of agarose may preferably be 1 to 5%.When the concentration of agarose is higher than the range above, themovement of the staining sample 140 may be delayed and a sufficientamount of the staining sample 140 may not move to the blood, and thus aproblem in which staining is not performed may occur. Conversely, whenthe concentration of agarose is lower than the range above, an excessivemovement of the staining sample 140 may occur and a superfluous amountof the staining sample 140 may be transferred to the blood. Althoughstaining can be smoothly performed when a superfluous amount of thestaining sample 140 is transferred, there may be disadvantages in whichthe staining sample 140 is wasted and a residue remains on the bloodsuch that washing and drying processes for removing the residue arerequired afterwards. Consequently, the concentration of agarose maypreferably be 1.5 to 2.5%.

Meanwhile, referring again to FIG. 5, when the contact-type stainingpatch 100 is brought into contact with the specimen T, the contact-typestaining patch 100 may either simply come into contact with the specimenT without any external pressure (only gravity acting during a simplevertical contact, but this may be viewed as having almost no pressure)or a predetermined pressure may be applied therebetween. This may beproperly selected according to a hardness of the contact-type stainingpatch 100. For example, a sufficient amount of the staining sample 140may be transferred to the specimen T with only a simple contact when thecontact-type staining patch 100 is manufactured to be somewhat soft, andconversely, a predetermined pressure may need to be applied for a properamount of the staining sample 140 to be transferred to the specimen Twhen the contact-type staining patch 100 is manufactured to be somewhathard.

When the contact-type staining patch 100 that directly comes intocontact with the specimen T to stain the specimen T is used, 1) stainingcan be performed under a correct reaction condition by only bringing thecontact-type staining patch 100 into contact with the specimen T eventhough the reaction condition is not separately adjusted; 2) a waste ofthe staining sample 140 can be minimized; and 3) there is an advantagein which a staining process is simplified due to the omission of apreprocessing process such as fixing the specimen T before staining or apostprocessing process such as washing and drying after staining.

Referring again to FIGS. 2 and 3, the staining solution has to bemanufactured impromptu for staining in the conventional blood smearexamination, and there is a problem of an error in staining being likelydue to a failure of setting a proper reaction condition due to atester's mistake. Alternatively, even when separate equipment thatproperly mixes the staining sample 140 with a solvent is used to addressthe problem above, not only is an additional cost required for buyingthe mixing equipment, but an inconvenience of having to perform themixing work each time the staining work is performed is also requiredsuch that there is a loss in terms of time and cost.

In contrast, the contact-type staining patch 100 according to anembodiment of the present disclosure stores the staining sample 140maintained at a proper reaction condition therein and staining iscorrectly performed by only bringing the contact-type staining patch 100into contact with the specimen T such that it is far more convenient andany one even someone who is not medical personnel can perform staining.

In addition, referring to FIGS. 2 and 3, staining is performed in theform of spraying a staining solution onto the slide S on which blood issmeared in the conventional blood smear examination, and there is aproblem in which a large amount of the staining sample 140 is wasted inthe above case. Not only is there great loss in terms of cost due to adifficulty of reusing the staining sample 140 that was sprayed once,there is a concern of negatively affecting the environment when thestaining sample 140 is left alone such that a burden of managing thestaining sample 140 is also added.

In contrast, the contact-type staining patch 100 according to anembodiment of the present disclosure transfers only a required amount ofthe staining sample 140 to blood by coming into contact with thespecimen T while the staining sample 140 or a staining solution isstored therein such that the staining sample 140 can be saved, andrecovery of the staining sample 140 after use is far more convenientsince the staining sample 140 in a gel phase is brought into contacttherewith instead of the staining sample 140 in a fluid form beingsprayed thereto.

Furthermore, since the contact-type staining patch 100 can be stored fora long period, the contact-type staining patch 100 is not discardedafter being used once and may also be used several times. Advantages interms of cost and environmental protection become even clearer when thecontact-type staining patch 100 is used several times.

In addition, referring to FIGS. 2 and 3, since staining is performed inthe form of spraying a staining solution onto blood in the conventionalblood smear examination, a preprocessing process of fixing blood on theslide S is required to prevent the blood from being swept away by thestaining solution.

In contrast, the contact-type staining patch 100 according to theembodiment of the present disclosure transfers the staining sample 140to blood through a simple contact such that, even when the specimen Tremains on the slide S or some blood is swept away toward thecontact-type staining patch 100 from the slide S in this process, onlysmall amounts thereof are involved, and thus the specimen T may not haveto be fixed on the slide S as needed. Of course, there may be cases inwhich fixating the specimen T is required to further optimize a testresult. However, the benefit of fixating the specimen T is similar tothe benefit generated due to the simplification of a test process suchthat the tester may select whether to fixate the specimen T with dueconsideration for the benefits.

In addition, referring to FIGS. 2 and 3, after the blood is stained, asprayed staining solution remaining on the slide S has to be removed andthus postprocessing such as washing and drying is required in theconventional blood smear examination.

In contrast, in the contact-type staining patch 100 according to anembodiment of the present disclosure, the staining sample 140 or thestaining solution is not excessively transferred to the slide S and thusresidue is prevented from remaining on the slide S such that a washingprocess may be omitted, and due to the omission of the washing process,a drying process may also be omitted.

Particularly, there is a problem in which an erroneous staining resultis brought about due to the washing process, e.g., an occurrence ofdecolorization when washing is performed for a long time, in theconventional blood smear examination. When the contact-type stainingpatch 100 according to an embodiment of the present disclosure is used,the washing process itself is unnecessary, and the erroneous stainingitself due to the washing process can be prevented.

1.3. Method of Manufacturing a Contact-Type Staining Patch

Hereinafter, a method of manufacturing the contact-type staining patch100 according to an embodiment of the present disclosure described abovewill be described.

An example of a method of manufacturing the contact-type staining patch100 may include forming the gel receptor 120 and absorbing the stainingsample 140 into the gel receptor 120.

First, the gel receptor 120 is formed using a gel raw material thatserves as a gel formation substance, a gelable substance, etc. such asagarose powder and the like. For example, the gel receptor 120 may bemanufactured when agarose powder and water are mixed at a proper ratio,and the mixture is heated and cooled. Here, boiling the mixture, bakingthe mixture using a microwave, or the like may be used as the heating.In addition, here, the cooling may include natural cooling or forcedcooling, and a stirring process may be included in the cooling asneeded.

Next, the staining sample 140 may be absorbed into the manufactured gelreceptor 120. To absorb the staining sample into the gel receptor 120, amethod in which the gel receptor 120 is dipped in a chamber, acontainer, or the like in which the staining sample 140 is accommodatedfor a predetermined amount of time and the gel receptor 120 is thentaken out after the staining sample 140 is sufficiently absorbedthereinto may be used.

In another example, the method of manufacturing the contact-typestaining patch 100 may include a method in which a gel raw material, anaqueous solution, and a staining sample are mixed to form a gelreceptor. For example, the contact-type staining patch 100 may bemanufactured by mixing agarose, an aqueous solution (or a bufferingsolution), and the staining sample 140 (which may be mixed with thebuffering solution) at a proper ratio, and heating and cooling themixture. Here, a heating and cooling means may be similar to theexamples described above.

In yet another example, the method of manufacturing the contact-typestaining patch 100 may include a method in which a gel raw material anda solution are mixed and heated and the staining sample 140 is theninjected during a process of cooling the heated mixture. For example,after agarose and an aqueous solution are mixed at a proper ratio andheated, the staining sample 140 may be injected during a process ofcooling the heated mixture.

1.4 Experimental Example of the Contact-Type Staining Patch

Hereinafter, an experimental example of the contact-type staining patch100 according to an embodiment of the present disclosure described abovewill be described.

In this experimental example, the contact-type staining patch 100according to an embodiment of the present disclosure is applied in aconventional Giemsa staining technique for an examination for malaria.

Meanwhile, since the Giemsa staining technique is merely described as arepresentative of Romanowsky staining techniques in various experimentalexamples which will be described below including this experimentalexample, embodiments are not limited to the Giemsa staining techniqueand may also be applied to other various Romanowsky staining techniques.In addition, a specimen staining technique performed using thecontact-type staining patch 100 described herein has a simple procedurewhile effects of conventional Romanowsky staining techniques and othervarious staining techniques are maintained, and thus is expected tosubstitute therefor. A specimen staining technique will be referred toas “Noul stain” in a paper which will be written by the applicants inrelation to the present disclosure.

The contact-type staining patch 100 was manufactured according to thefollowing protocol.

1) After agarose, Giemsa powder, and the buffering solution B weremixed, the mixture was boiled and then cooled at room temperature.Agarose was used at 2% concentration, and the buffering solution Bhaving a pH of 7.2 was used. Also, the mixture was heated to 100° C. orhigher. Here, the concentration of agarose may be adjusted within arange of 1 to 3%. In addition, a pH concentration of the bufferingsolution B may be adjusted in a pH range of 6.4 to 7.6.

The contact-type staining patch 100 manufactured in this way was placedon blood smeared in a monolayer on the slide S for approximately fiveminutes, and then the staining result was observed using a 100×microscope. Blood collected from a mouse infected with plasmodium (amalaria-causing protozoan) was used.

FIG. 7 is an image of a result of staining using a standard Giemsa stainprocess, i.e. a Giemsa staining technique, according to a conventionalfluid spraying means, FIG. 8 shows images of results of staining usingthe Giemsa staining technique according to a standard Giemsa stainprocess for each pH concentration, and FIG. 9 is an image of a result ofstaining using the Giemsa staining technique in which the contact-typestaining patch 100 according to an embodiment of the present disclosureis applied.

FIG. 7 is a result of staining in which a proper pH concentration of theGiemsa stain is followed whereas FIG. 8 is a result of staining of acase in which a pH concentration deviates from a proper value during astaining process. Referring to FIG. 9, a result in which thecontact-type staining patch 100 above is applied in the Giemsa stainingtechnique shows a similar result with a correct staining result in whicha proper pH concentration is followed. This suggests that staining usingthe contact-type staining patch 100 has been properly performed.

Particularly, a staining solution sprayed onto the slide S on whichblood is smeared in the standard Giemsa stain process takes twenty tothirty minutes or more to stain. In contrast, when the contact-typestaining patch 100 is used, the same result can be obtained within fiveminutes or less. Further, preparing a staining solution or washing,drying, etc. after staining is performed takes at least tens of minutesin the conventional standard process. In contrast, when the contact-typestaining patch 100 is used, observation using a microscope isimmediately possible after approximately tens of seconds of naturaldrying after staining is performed such that a time reduction effect iseven greater.

Meanwhile, the contact-type staining patch 100 for an examination thesame as that above may also be manufactured according to the followingprotocol.

2) After 0.4 g of agarose is mixed with 20 ml of a mixed solution of thebuffering solution B having a pH of 7.2, the mixture is heated forthirty seconds using a microwave and cooled while being stirred. Then, 1ml of a Giemsa modified solution is mixed therewith, and the mixture isfurther cooled and then hardened to a gel phase.

The contact-type staining patch 100 manufactured in this way was placedon blood smeared in a monolayer on the slide S for approximately fiveminutes, and then the staining result was observed using a 100×microscope. Blood collected from a mouse infected with plasmodium (amalaria-causing protozoan) was used.

FIG. 10 is an image of another result of staining using the Giemsastaining technique in which the contact-type staining patch 100according to an embodiment of the present disclosure is applied.Referring to FIG. 10, a result in which the contact-type staining patch100 manufactured using microwave baking described above is applied inthe Giemsa staining technique also shows a similar result with a correctstaining result in which a proper pH concentration is followed. Thus,this case also suggests that staining using the contact-type stainingpatch 100 has been properly performed.

In consideration of the staining results, the contact-type stainingpatch 100 according to an embodiment of the present disclosure isexpected to have a more stable staining performance than a stainingmethod that is performed according to the conventional standard process.

Although experimental examples in which the contact-type staining patch100 is applied in the Giemsa staining technique has been describedabove, it should be self-evident that the contact-type staining patch100 can also be applied to other different staining techniques.

FIG. 11 is a view illustrating results according to a standard stainingtechnique and a staining technique in which the contact-type stainingpatch 100 is applied with respect to a Wright staining technique.

For the contact-type staining patch 100 for the Wright stain, agel-phase contact-type staining patch 100 was manufactured using astaining solution in which the buffering solution B having a pH of 6.8was mixed with the Wright staining sample 140 and agarose. FIG. 11 showsa result of observation using a 400× microscope after the contact-typestaining patch 100 was placed on the specimen T for approximately fiveminutes. As illustrated in FIG. 11, in the case of the Wright stainingtechnique, it was also confirmed that a result almost the same as thataccording to the standard process was acquired.

FIG. 12 is a view illustrating a result according to a stainingtechnique in which the contact-type staining patch 100 is applied withrespect to a DAPI staining technique.

For the contact-type staining patch 100 for a DAPI stain, a gel-phasecontact-type staining patch 100 was manufactured using 0.4 g of agarose,20 ml of PBS, and 20 μl of DAPI. FIG. 12 shows results of observationswhich each used a Bright 20× and a Fluorescence 20× after thecontact-type staining patch 100 was placed on the specimen T forapproximately five minutes. As illustrated in FIG. 12, in the case ofthe DAPI staining technique, a stable fluorescent color formation wasalso confirmed as a result thereof.

In consideration of the staining results, the contact-type stainingpatch 100 according to an embodiment of the present disclosure isexpected to simplify most of the standard processes of stainingtechniques that are conventionally performed as well as substitutetherefor by guaranteeing a stable staining performance.

1.5. Utilization of the Contact-Type Staining Patch

In consideration of the above, representative examples of utilizing thecontact-type staining patch 100 are as follows.

1.5.1 Staining Patch

In a conventional staining technique used in hematology, a liquid-phasestaining solution was sprayed onto blood cells or tissue. However, withthis method, residue remains on the specimen T, and it was difficult tocontrol washing and drying processes, which are essential for removingthe residue, to be regular. In addition, since a result sensitivelychanges according to a method of manufacture, a manufacture period, achange in a pH concentration of a buffer, etc. of staining reagentswhich are used, it was difficult to gain a stable staining result.Furthermore, the conventional standard processes required various typesof equipment and, due to a great complexity of a protocol using theequipment, it was extremely difficult for an unskilled person to carryout the protocol.

A staining patch is an innovative improvement of the conventionalstaining technique and basically refers to a gel-phase receptor thatholds the staining sample 140 in a hydrogel state. The staining patchmay be manufactured by properly combining staining powder, hydrogel, thebuffering solution B, a stabilizer, water, etc. as needed and enables asimple protocol in which staining is completed by the manufacturedstaining patch being brought into contact with and separated from bloodcells or tissue for a relatively short amount of time.

The method has advantages in that washing and drying processes can beomitted from an overall staining process, an amount of time for stainingitself is short, there is no residue such as a stain remaining on thespecimen T, the use of samples can be minimized, and results are regularand stable compared to the conventional method.

As a result, the staining patch creates a reaction condition (or anenvironmental condition) in a staining process while holding water suchthat a chemical reaction is induced between the staining sample 140 anda substance to be reacted with while the water and other buffersubstance are maintained as they are in the hydrogel, thereby notrequiring the washing and drying processes.

Representative examples of the staining patch may include Romanowskystaining patches, such as a Giemsa patch and a Wright patch, and aPapanicolaou staining patch.

1.5.2. Antibody Patch

In performing immunohistochemistry or an enzyme linked immunosorbentassay (ELISA), an antibody patch is a patch capable of being deliveredin a hydrogel state instead of a conventional liquid state in order todeliver an antibody or an antibody to which reporters such as afluorescent substance are coupled.

Similar to the staining patch, the antibody patch is brought intocontact with blood or a tissue for a predetermined amount of time. Bythis contact, antibodies stored inside a gel exit the antibody patchaccording to an antigen-antibody reaction, and the reaction ends.

When the antibody patch is used, a result may be obtained more promptlythan the conventional means, washing and drying processes can beomitted, and background noise can be minimized.

1.5.3. DNA Patch

In performing the FISH test and the like, a DNA patch is a patch whichdelivers a DNA probe to which a fluorescent substance reporter iscoupled, and is a patch that is delivered in a hydrogel state instead ofa conventional liquid state.

Similar to the staining patch, the DNA patch is brought into contactwith the specimen T such as blood, a tissue, or the like for apredetermined amount of time and then detached therefrom. By thiscontact, DNA probes exit the patch for hybridization, and the reactionends.

Also in a DNA test, when the DNA patch is used, a more prompt andaccurate result can be obtained compared to the conventional method, andwashing and drying processes can be omitted.

Various examples of utilizing the contact-type staining patch 100 havebeen described above. However, fields in which the contact-type stainingpatch 100 can be utilized are not limited to those described above, andthe contact-type staining patch 100 may be utilized in other varioustypes of staining (a “wide meaning” defined herein which is inducingdetection when a specimen is tested). Here, the staining sample 140 maybe properly selected according to a field in which the contact-typestaining patch 100 is utilized. For example, a staining substance may beused as the staining sample 140 in a case of a staining patch; anantibody may be used as the staining sample 140 in a case of an antibodypatch; and a DNA probe may be used as the staining sample 140 in a caseof a DNA patch.

2. Contact-Type Staining Supplementary Patch 100

The contact-type staining patch 100 that contains the staining sample140 reacting with a substance to be reacted with of the specimen T hasbeen described above. Hereinafter, a contact-type staining supplementarypatch 100′ according to an embodiment of the present disclosure thatperforms other processes performed throughout a staining process, e.g.,fixing or buffering, decolorizing, mordanting, washing, etc. of thespecimen T. will be described.

2.1. Examples of the Contact-Type Staining Supplementary Patch

A configuration of the contact-type staining supplementary patch 100′ isbasically substantially the same as that of the contact-type stainingpatch 100. Specifically, like the contact-type staining patch 100, thecontact-type staining supplementary patch 100′ includes the gel receptor120 and may include a staining enhancing agent 160 instead of thestaining sample 140.

The staining enhancing agent 160 may be selected according to a field inwhich the contact-type staining supplementary patch 100′ is used.

2.1.1. Fixing Patch

For example, when being used to fix the specimen T, the stainingenhancing agent 160 may be a specimen fixing agent such as alcohol(ethanol, methanol, or the like) that fixes the specimen T onto theslide S and the like.

2.1.2. Decolorizing Patch and Mordanting Patch

In another example, when the staining enhancing agent 160 is used fordecolorizing or mordanting, a decolorizing agent or a mordanting agentmay be used as the staining enhancing agent 160. In a Gram stainingtechnique, after both Gram-positive bacteria and Gram-negative bacteriaare stained using crystal violet as a main staining agent, the mainstaining agent is fixed to the Gram-positive bacteria using iodine asthe mordanting agent, the main staining agent not fixed to theGram-negative bacteria is then peeled off from the Gram-negativebacteria using a decolorizing agent such as alcohol (ethanol, methanol,etc.), and the decolorized Gram-negative bacteria is stained usingsafranin as a contrast staining agent such that the Gram-positivebacteria are stained by the main staining agent and the Gram-negativebacteria are stained by the contrast staining agent, and thus the twoexhibit colors different from each other as a result. In this process,when actual staining is constituted only of the main staining agent andthe contrast staining agent, the mordanting agent and the decolorizingagent do not perform staining itself but perform roles of assisting instaining. In the Gram staining technique, a main staining patch thatuses crystal violet (a main staining agent) as the staining sample 140and a contrast staining patch that uses safranin 0 (a contrast stainingagent) as the staining sample 140 are prepared as the contact-typestaining patch 100 according to an embodiment of the present disclosure,and a mordanting patch that contains iodine (a mordanting agent) as thestaining enhancing agent 160 and a decolorizing patch that containsalcohol (a decolorizing agent) as the staining enhancing agent 160 areprepared as the contact-type staining supplementary patch 100′ accordingto an embodiment of the present disclosure such that the Gram stainingtechnique can be performed by bringing the main staining patch, themordanting patch, the decolorizing patch, and the contrast stainingpatch into contact with the specimen T in that order.

When the contact-type staining supplementary patch 100′ such as thefixing patch and the decolorizing patch is manufactured using the fixingagent or the decolorizing agent described above, a non-hydrogel may bemainly used for a material of the gel receptor 120 (of course, hydrogelmay also be used according to circumstances). Alcohol with a highconcentration (e.g., 99% or higher) may have to be used as the fixingagent to fix the specimen T on the slide S. Here, when hydrogel is used,the concentration of alcohol may be lowered due to an interactionbetween the gel receptor 120 and the alcohol, and accordingly, a fixingaction may be degraded. In contrast, when the gel receptor 120 is anon-hydrogel, the concentration of alcohol can be maintained relativelywell in the above case, and thus fixing performance or decolorizingperformance can be improved. A PDMS gel, a PMMA gel, a silicone gel, orthe like may be used as the non-hydrogel.

In addition, the fixing patch or the decolorizing patch may also bereplaced with a fixing agent or a decolorizing agent that are a resultof solidifying the gel receptor 120. For example, solidified-methanolitself may also be used as the fixing patch or the decolorizing patch.

2.1.3. Buffering Patch

In yet another example, there may be a buffering patch that uses thebuffering solution B as the staining enhancing agent 160. The bufferingpatch may be a patch that creates a reaction condition (an environmentalcondition) for staining at the specimen T by coming into contact withthe specimen T before, after, or both before and after the staining ofthe specimen T. In the case of the Giemsa stain, the buffering patch maybe provided in a form in which the buffering solution B having a pHproper for the Giemsa stain is accommodated in the gel receptor 120.

A pH of the buffering solution B to be contained in the buffering patchmay be substantially the same as a pH according to the reactioncondition, i.e., an optimal pH.

Alternatively, unlike the above, the pH of the buffering solution B maybe somewhat different from the optimal pH for a reaction.

When staining is performed, creating a proper staining environment, inparticular, creating a proper pH, may be an important factor forproperly performing staining. Generally, in a buffering step of theconventional staining procedure, a pH condition is set by spraying orspilling the buffering solution B having an optimal pH onto a specimenthat is stained, being stained, or will be stained. In contrast, in abuffering step using the contact-type staining supplementary patch 100′,a pH condition is created at a specimen by bringing the buffering patchinto contact with the specimen T. Consequently, the contact-typestaining supplementary patch 100′ causes a buffering action in thespecimen T according to a mechanism different from a conventional meansin which a buffering solution in a liquid phase is brought into contactwith a specimen.

Specifically, when a buffering patch manufactured using the bufferingsolution B that has an approximate pH of 6.5 is brought into contactwith the specimen T that is stained and the stained specimen T isobserved, a staining result similar to a result of spraying thebuffering solution B having an approximate pH of 7.2 to 7.4 onto thespecimen T that is stained is actually observed.

In consideration of the point above, it can be recognized that a pHcreated at the specimen T when the buffering solution B is provided tothe specimen T while being contained in the gel receptor 120 is somewhatmore biased toward a neutral pH than a pH created when the bufferingsolution B is directly sprayed onto the specimen T in a liquid phase.This is because, when the buffering solution B is directly providedusing the buffering patch, an acid-base interaction that occurs betweenthe buffering solution B and the specimen T occurs through the meshstructure of the gel matrix and thus may be somewhat delayed than anacid-base interaction between the buffering solution B sprayed in aliquid phase and the specimen.

In other words, an effective pH of the buffering patch manufacturedusing the buffering solution B having a specific pH value is somewhatmore biased toward a neutral pH than a pH value of the bufferingsolution B itself. Here, the effective pH refers to a pH acting at thespecimen T and may be, for example, a pH created at the specimen T whenthe buffering solution B in a liquid phase is sprayed onto the specimen.

Consequently, when the buffering patch is being manufactured, a pH ofthe buffering solution B has to be adjusted so that an effective pHvalue of the buffering patch is substantially the same as an optimal pHvalue of a staining technique in which the buffering patch will be usedfor buffering.

That is, a pH value of the buffering solution B itself that will be usedin the buffering patch may be set as a value compensated for by a pHcompensation value in consideration of an extent to which an acid-baseinteraction is hindered by the gel matrix with respect to an optimal pHvalue which facilitates staining that may be defined in a conventionalstaining technique.

Here, the pH compensation value may be a negative value when the optimalpH is acidic. For example, the pH compensation value may be −0.3 whenthe optimal pH is 6.8, and accordingly, a pH value of the bufferingsolution B used when the buffering patch is manufactured may be a pH of6.5 for the effective pH of 6.8.

In addition, here, the pH compensation value may be a positive valuewhen the optimal pH is basic. For example, the pH compensation value maybe +0.2 when the optimal pH is 7.4, and accordingly, a pH value of thebuffering solution B used when the buffering patch is manufactured maybe a pH of 7.6 for the effective pH of 7.4.

A size (i.e., an absolute value) of the pH compensation value may beincreased or decreased according to a concentration, a hardness,porosity, a density of a mesh structure, etc. of the gel of the gelreceptor 120. The size of a pH compensation value may increase as aconcentration of the gel of the gel receptor 120 increases, and the sizeof the pH compensation value may decrease as the concentration of thegel lowers. For example, when agarose gel is used as the gel receptor120, the size of the pH compensation value may increase as aconcentration of agarose increases, and the size of the pH compensationvalue may decrease as a concentration of agarose lowers.

In addition, the size of the pH compensation value may increase as thegel receptor 120 hardens, and the size of the pH compensation value maydecrease as the gel receptor 120 softens.

In addition, the size of the pH compensation value may decrease as theporosity of the gel receptor 120 increases, and the size of the pHcompensation value may increase as the porosity decreases.

In addition, the size of the pH compensation value may increase as thedensity of the mesh structure of the gel receptor 120 increases, and thesize of the pH compensation value may decrease as the density lowers.

A pH shift phenomenon of the buffering patch is caused by a causedifferent from a case in which a pH of the buffering solution B isshifted when the staining sample 140 is mixed with the bufferingsolution B in the contact-type staining patch 100. That is, although pHshifting in the buffering patch occurs due to a cause described justabove, pH shifting in the contact-type staining patch 100 may occur dueto a complex cause that includes the cause described just above and acause according to a part of description related to the bufferingsolution B of the contact-type staining patch 100.

Meanwhile, the above description on the pH compensation of the bufferingsolution B is not applied only to the buffering solution B included inthe buffering patch but may be generally applied to the contact-typestaining patch 100 or the contact-type staining supplementary patch 100′that has the buffering solution B. For example, even when the stainingsample 140 included in the contact-type staining patch 100 is in a formof a solution in which a staining powder is mixed with the bufferingsolution B, a pH value that results from adding or subtracting a pHcompensation value to or from an optimal pH may be set as a pH value ofthe buffering solution B instead of making the pH value of the bufferingsolution B correspond to the optimal pH.

2.1.4. Washing Patch

In still another example, there may be a washing patch. The washingpatch is a patch that performs washing during a staining process and,somewhat different from the contact-type staining supplementary patch100′ described above, may not include a separate staining enhancingagent 160 or may use a small amount of water, alcohol, or the like asthe staining enhancing agent 160.

The washing patch comes into contact with the specimen T to perform arole of removing foreign substances and the like remaining on thespecimen T. For example, when a dye, a mordanting agent, a decolorizingagent, a fixing agent, or the like is applied to the specimen T during astaining process, some of whatever is applied remains on the specimen Tand needs to be washed away. When the washing patch is brought intocontact with the specimen T, the specimen T may be washed as a foreignsubstance is absorbed into a pore of the gel matrix of the washingpatch. This is due to a property of the washing patch for absorbing acontacted foreign substance since the washing patch does not contain asolution and the like therein or contains only a small amount thereof.

Since the washing patch also performs a function of absorbing a liquidon the specimen T and simultaneously performs washing and drying thespecimen T in the staining process, the washing patch may also bereferred to as a drying patch.

Meanwhile, the washing and drying functions of the washing patch mayalso be performed by the buffering patch other than the washing patch.In a case of the buffering patch, since a relatively larger amount ofsolution is included inside the gel receptor 120 compared to the washingpatch, performance of absorbing a foreign substance on the specimen Twhen brought into contact with the specimen T may be somewhat low.However, since the gel receptor 120 of the buffering patch also has somepores, the buffering patch may somewhat perform a function of absorbingresidue on the specimen T. As a result, the buffering patch is able toperform some of washing and drying roles besides a buffering role inwhich an optimal pH is set with respect to the specimen T. Thus,buffering, washing, and drying are performed by only simply bringing thebuffering patch into contact with the specimen T, and accordingly, thestaining process can be simplified. Of course, performing separatewashing and drying processes is possible when an excessive amount ofresidue is present.

Meanwhile, an absorbent may also be contained as the staining enhancingagent 160 in the gel receptor 120 of the washing patch to reinforce anabsorption force of the washing patch. The porosity of the gel receptor120 may be improved by not injecting a separate solution in the gelreceptor 120 or injecting only a small amount of a solution therein asdescribed above so that a foreign substance may be well-absorbed fromthe specimen T it contacts. However, when the absorbent is injected asthe staining enhancing agent 160 in the gel receptor 120 to furtherimprove the absorption force, an absorption rate may be improved byabsorbing the foreign substance on the specimen T with which theabsorbent has come into contact.

2.1.5. Composite Patch

Meanwhile, although each function of the contact-type stainingsupplementary patch 100′ has been described above, the contact-typestaining supplementary patch 100′ may simultaneously have two or morefunctions in some cases.

For example, the buffering patch may simultaneously perform a role ofbuffering a reaction condition such as a pH concentration at thespecimen T which is stained and a role of washing residue remaining onthe specimen T. Although there is substantially almost no residueremaining at the specimen T when the specimen T is stained using thecontact-type staining patch 100 according to an embodiment of thepresent disclosure, even an infinitesimal amount of residue that may bepresent at the specimen T may be clearly removed when the contact-typestaining patch 100 is detached from the specimen T and then thebuffering patch is brought into contact with the specimen T.

In addition, meanwhile, although it has been described above that thecontact-type staining supplementary patch 100′ is implemented with onepatch for each role, one contact-type staining supplementary patch 100′may contain a composite staining enhancing agent 160 and perform two ormore roles unlike the above description.

For example, the mordanting patch and the decolorizing patch may beimplemented as one mordanting-and-decolorizing patch. Themordanting-and-decolorizing patch in which the mordanting agent and thedecolorizing agent are simultaneously stored as staining enhancingagents 160 in the gel receptor 120 may simultaneously perform mordantingand decolorizing of the specimen T when brought into contact with thespecimen T.

Furthermore, the contact-type staining patch 100 and the contact-typestaining supplementary patch 100′ may also be implemented by beingcombined with each other. For example, when the main staining agent, themordanting agent, the decolorizing agent, and the contrast stainingagent for the Gram staining technique may be accommodated in the gelreceptor 120, the contact-type staining patch 100 and the contact-typestaining supplementary patch 100′ may be implemented using one patch(hereinafter referred to as a “composite patch”).

The composite patch extremely simplifies the staining process, thushaving an advantage of being convenient to use. However, when reactionsoccur between staining samples 140, between staining enhancing agents160, and between the staining samples 140 and the staining enhancingagents 160 inside the gel receptor 120, staining may fail or anerroneously stained result may be obtained. Thus, the composite patchshould be used in proper consideration of its advantages anddisadvantages.

2.2. Method of Manufacturing a Contact-Type Staining Supplementary Patch

Hereinafter, a method of manufacturing the contact-type stainingsupplementary patch 100′ according to an embodiment of the presentdisclosure described above will be described.

An example of the method of manufacturing the contact-type stainingsupplementary patch 100′ may include forming the gel receptor 120 andabsorbing the staining enhancing agent 160 into the gel receptor 120.

First, the gel receptor 120 is formed using a gel raw material thatserves as a gel formation substance, a gelable substance, etc. such asagarose powder and the like. For example, the gel receptor 120 may bemanufactured when agarose powder and water are mixed at a proper ratio,and the mixture is heated and cooled. Here, boiling the mixture, bakingthe mixture using a microwave, or the like may be used as the heating.In addition, here, the cooling may include natural cooling or forcedcooling, and a stirring process may be included in the cooling asneeded.

Next, the staining enhancing agent 160 can be absorbed into themanufactured gel receptor 120. To absorb the staining enhancing agent160 into the gel receptor 120, a method in which the gel receptor 120 isdipped in a chamber, a container, or the like in which the stainingenhancing agent 160 is accommodated for a predetermined amount of timeand the gel receptor 120 is then taken out after the staining enhancingagent 160 is sufficiently absorbed thereinto may be used.

In another example, the method of manufacturing the contact-typestaining supplementary patch 100′ may include a method in which a gelraw material, an aqueous solution, and a staining sample are mixed toform a gel receptor. For example, the contact-type stainingsupplementary patch 100′ may be manufactured by mixing agarose, anaqueous solution (or a buffering solution), and the staining enhancingagent 160 at a proper ratio, and heating and cooling the mixture. Here,the heating and cooling means may be similar to the examples describedabove.

In yet another example, the method of manufacturing the contact-typestaining supplementary patch 100′ may include a method in which a gelraw material and a solution are mixed and heated, and the stainingenhancing agent 160 is then injected during a process of cooling theheated mixture. For example, after agarose and an aqueous solution aremixed at a proper ratio and heated, the staining enhancing agent 160 isinjected during a process of cooling the heated mixture.

2.3. Experimental Example of the Contact-Type Staining SupplementaryPatch

Hereinafter, an experimental example of the contact-type stainingsupplementary patch 100′ according to an embodiment of the presentdisclosure described above will be described.

In this experimental example, the contact-type staining patch 100 andthe contact-type staining supplementary patch 100′ according to anembodiment of the present disclosure are applied in the conventionalGiemsa staining technique for an examination for malaria.

Two contact-type staining patches 100 were manufactured to respectivelyhave methylene blue and eosin which are Giemsa staining samples 140 asone sample.

Manufacturing a plurality of patches for each sample as above may havean advantage in which a storage period of the contact-type stainingpatch 100 is longer than in a case in which the patch is manufactured bymixing two staining samples 140 in one patch. To give a concreteexample, when methylene blue and eosin are mixed and accommodated in onecontact-type staining patch, methylene blue, which is basic, and eosin,which is acidic, may react with each other as time passes, and thusreactivity with respect to the specimen T may be degraded. On the otherhand, when the contact-type staining patch 100 is separatelymanufactured for methylene blue and eosin, such a problem may bemitigated.

A specific manufacturing protocol is as follows.

1) After agarose, methylene blue, and the buffering solution B weremixed, the mixture was boiled or baked using a microwave and then cooledat room temperature to manufacture a methylene blue staining patch.

2) After agarose, eosin, and the buffering solution B were mixed, themixture was boiled or baked using a microwave and then cooled at roomtemperature to manufacture an eosin staining patch.

In processes 1) and 2), agarose having a concentration of 1 to 5% wasused, and a pH concentration of the buffering solution B was set as anoptimal pH of the staining sample 140 in each case.

Then, the contact-type staining supplementary patch 100′ wasmanufactured according to the following protocol.

3) After only agarose and the buffering solution B were mixed withoutthe staining sample 140, the mixture was boiled or baked using amicrowave and then cooled at room temperature to manufacture a bufferingpatch. Here, a PBS solution having a pH of 7.2 was used as the bufferingsolution B.

The methylene blue patch, the eosin patch, and the buffering patchmanufactured as above were sequentially brought into contact with anddetached from blood smeared on the slide S in that order. Here, themethylene blue patch was brought into contact with the blood forapproximately thirty seconds and the eosin patch was brought intocontact with the blood for approximately one minute. Then, the bufferingpatch was brought into contact with the blood for approximately threeminutes.

FIG. 13 is a view illustrating a staining result observed before abuffering patch is brought into contact with blood after a methyleneblue patch and an eosin patch are brought into contact with the blood,and FIG. 14 is a view illustrating a staining result observed after thebuffering patch is brought into contact with blood after the methyleneblue patch and the eosin patch are brought into contact with the blood.

When FIGS. 13 and 14 are compared, it can be recognized that FIG. 13 ismore similar to a result of normal staining according to a standardstaining process of the Giemsa stain. Specifically, in FIG. 13, a bluecolor (methylene blue) is intensively stained compared to FIG. 14, and ared color stained by eosin is relatively not observed. This is because areaction of eosin injected into blood later is hindered by methyleneblue that has come into contact with blood before the eosin. When thebuffering patch is brought into contact with blood in this state, normalstaining is performed by decreasing an excessive reaction of methyleneblue while increasing an insufficient reaction of eosin as a reactioncondition (a pH concentration and the like) on the blood is adjusted toan optimal pH which is proper for the reaction.

In addition, when FIGS. 13 and 14 are closely examined, it can berecognized that stains and the like (an upper left side in FIG. 11) thatwere observed before the contact with the buffering patch were removedafter the contact with the buffering patch.

In consideration of these points, when the staining samples 140 are usedin combination, it can be recognized that the buffering patchsimultaneously performs a function of properly creating a reactioncondition so that each of the staining samples 140 reacts well and awashing function to remove a foreign substance.

In addition, since an excessive amount of the buffering solution Bstored in the buffering patch is not moved toward blood, i.e., thespecimen T, an additional drying procedure may be omitted or only aminimal drying procedure may be required.

3. Test Kit

Hereinafter, a test kit 1000 according to an embodiment of the presentdisclosure will be described.

The test kit 1000 according to an embodiment of the present disclosuremay have the contact-type staining patch 100 stored therein to stain thespecimen T when the specimen is injected thereinto.

3.1. Configuration of the Test Kit

The test kit 1000 may include two plates. Here, one of the two platesmay be a plate 1200 (hereinafter, referred to as “patch plate”) thatstores the contact-type staining patch 100, and the other one of the twoplates may be a plate 1400 (hereinafter, referred to as “specimenplate”) that receives the specimen T. In the test kit 1000, the twoplates, i.e. the patch plate 1200 and the specimen plate 1400 may becoupled to be relatively movable. Here, moving is a concept thatencompasses sliding or rotating.

In the test kit 1000, when the specimen T is injected onto the specimenplate 1400, the patch plate 1200 may move relative to the specimen plate1400 so that the contact-type staining patch 100 stored in the patchplate 1200 is disposed on a point at which the specimen T is injected tobring the specimen T and the contact-type staining patch 100 intocontact with each other to stain the specimen T.

FIG. 15 is an exploded perspective view of an example of the test kit1000 according to an embodiment of the present disclosure, and FIG. 16is a coupled perspective view of the example of the test kit 1000according to an embodiment of the present disclosure.

Referring to FIGS. 15 and 16, the specimen plate 1400 may have adisk-shaped body 1402 in the test kit 1000. In addition, the patch plate1200 may have a body 1202 in the shape of a disk with an incised portion(e.g., a sector-shaped plate). The patch plate 1200 and the specimenplate 1400 may be provided to face each other and may be coupled to eachother to be relatively rotatable at a central portion of the disk or thesector-shaped plate.

The bodies 1202 and 1402 of the patch plate 1200 and the specimen plate1400 may each have an inner surface, an outer surface, and a sidesurface. Here, the inner surfaces are surfaces of the patch plate 1200and the specimen plate 1400 that face each other, and the outer surfacesare surfaces opposite to the inner surfaces. That is, an inner surface1204 of the patch plate 1200 is a surface close to the specimen plate1400, an outer surface of the patch plate 1200 is a surface away fromthe specimen plate 1400, an inner surface 1404 of the specimen plate1400 is a surface close to the patch plate 1200, and an outer surface ofthe specimen plate 1400 is a surface away from the patch plate 1200.

The patch plate 1200 and the specimen plate 1400 may be coupled to eachother at central portions thereof. For example, as illustrated in FIGS.15 and 16, a coupling protrusion 1208 that protrudes toward the innersurface may be formed on any one of the central portions of the patchplate 1200 and the specimen plate 1400, and a coupling hole 1408 or acoupling groove may be formed at the other central portion such that thepatch plate 1200 and the specimen plate 1400 may be coupled to eachother by inserting the coupling protrusion 1208 into the coupling hole1408 or the coupling groove. Here, to stabilize coupling between the twoplates, a nut may be connected to an end portion of the couplingprotrusion that has passed through the coupling hole, a wing thatextends from the end portion of the coupling protrusion in a diameterdirection thereof may be formed, or the two plates may be coupled toeach other using a separate pin.

Meanwhile, the patch plate 1200 and/or the specimen plate 1400 may beprovided with a transparent or semitransparent material. When the patchplate 1200 and/or the specimen plate 1400 is transparent orsemitransparent, there may be an advantage in which a tester can check astaining process using the test kit 1000 with his or her naked eye.

3.2. Structure of the Patch Plate

FIG. 17 is a perspective view of an example of the patch plate 1200according to an embodiment of the present disclosure.

Referring to FIG. 17, the patch plate 1200 may have a body in the shapeof a disk with an incised portion (e.g., a sector-shaped plate).

A storage unit 1220 that stores the contact-type staining patch 100 orthe contact-type staining supplementary patch 100′ may be formed at thebody. Hereinafter, the contact-type staining patch 100 and thecontact-type staining supplementary patch 100′ will be collectivelyreferred to as a “contact-type patch.”

The storage unit 1220 may be formed on a sector-shaped area of the patchplate 1200 and, more particularly, may be formed at a position spacedapart from the center of the patch plate 1200 by a predetermineddistance in a radial direction thereof.

One or a plurality of storage units 1220 may be formed at the patchplate 1200. For example, when attempting to stain blood according to theGiemsa staining technique, the number of storage units 1220 of the patchplate 1200 may be as follows. At the patch plate 1200, 1) only onestorage unit 1220 for storing only a methylene blue-eosin patch (thecontact-type staining patch 100 that simultaneously contains twostaining samples 140, methylene blue and eosin) may be formed, 2) onlytwo storage units 1220 for storing the methylene blue patch and an eosinpatch, respectively, may be formed, or 3) three storage units 1220 forstoring the methylene blue patch, the eosin patch, and a bufferingpatch, respectively, may be formed. For reference, FIG. 17 illustratesthe patch plate 1200 at which two storage units 1220 are formed.

When there are the plurality of storage units 1220, an angle formed byeach of the storage units 1220 with respect to the center of the patchplate 1200 when viewed in a direction of the inner surface of the patchplate 1200 may be uniform. For example, from the center of the patchplate 1200, an angle between a first storage unit 1220-1 and a secondstorage unit 1220-2 and an angle between the second storage unit 1220-2and a third storage unit 1220-3 may be 45°. When angular intervalsbetween the storage units 1220 are set to be equal to each other, thereis an advantage of being easy to control a diagnostic device which willbe described below since the contact-type patches can be sequentiallybrought into contact with the specimen T by being rotated the same asthe angles.

The storage unit 1220 may store the contact-type staining patch 100 orthe contact-type staining supplementary patch 100′ so as to be exposedin a direction of the inner surface of patch plate 1200.

For example, as illustrated in FIG. 17, the storage unit 1220 may beformed in a form of a groove. The groove may be in a form in which thedirection of the inner surface of the patch plate 1200 is open, i.e. aform recessed in the direction of the inner surface of the patch plate1200. Accordingly, the contact-type patch to be stored in the storageunit 1220 may come into contact with the specimen T to be injected ontothe specimen plate 1400.

Here, the groove may have a form corresponding to the contact-type patchto be stored therein.

Meanwhile, although the contact-type patch may be manufactured invarious shapes, for convenience of description, a description will begiven based on a contact-type patch manufactured in a cylindrical orpolygonal cylindrical shape having main surfaces which are circular orpolygonal upper surface, lower surface, and side surfaces that connectthe upper surface and the lower surface to each other. Of course, thecontact-type patch may also be manufactured in various other shapesincluding a hemispherical shape, a cylindrical or polygonal cylindricalshape in which sizes of an upper surface and a lower surface aredifferent, and a cylindrical or polygonal cylindrical shape in which aside surface has a convex shape.

FIG. 18 is a cross-sectional view of an example of the storage unit 1220in a groove form according to an embodiment of the present disclosure.

Referring to FIGS. 17 and 18, a groove 1220′ may have an open surface1222, a bottom surface 1224, and a side surface 1226.

When the groove 1220′ is viewed in the direction of the inner surface1204, the open surface 1222 and the bottom surface 1224 of the groove1220′ may have the same form as main surfaces of the contact-type patch.Here, when the groove 1220′ is viewed in the direction of the innersurface 1204, at least one of the open surface 1222 and the bottomsurface 1224 of the groove 1220′ may have a size equal to or smallerthan the main surfaces of the contact-type patch. When the size of theopen surface 1222 or the bottom surface 1224 of the groove 1220′ issmaller than that of the main surfaces of the contact-type patch, thestorage unit 1220 may stably store the contact-type patch as thecontact-type patch is stored in the groove in a somewhat compressedstate.

A depth of the side surface 1226 of the groove 1220′ may be the same orsmaller than that of the contact-type patch. When the depth of the sidesurface 1226 of the groove 1220′ is smaller than that of thecontact-type patch, a portion of the contact-type patch stored in thegroove protrudes from the inner surface of the patch plate 1200, andaccordingly, contact between the contact-type patch and the specimen Ton the specimen plate 1400 may be further facilitated.

A deviation preventing means that prevents the contact-type patch storedin the groove 1220′ from deviating may be provided at the groove 1220′.

For example, the deviation preventing means may be implemented as adeviation preventing step that extends from the side surface 1226touching the open surface 1222 of the groove 1220′ toward a centralportion of the open surface 1222. The contact-type patch stored in thestorage unit 1220 is locked to the open surface 1222 of the groove bythe deviation preventing step and thus is prevented from deviating tothe outside.

In another example, the deviation preventing means may be implemented asa deviation preventing protrusion that extends from the side surface of1226 of the groove 1220′ toward the central portion of the groove 1220′.Due to being compressed and stored in the storage unit 1220 by thedeviation preventing protrusion, the contact-type patch is stably fixedto the storage unit 1220, and thus does not deviate to the outside.

In yet another example, when the side surface 1226 of the groove 1220′is formed in a form of being gradually inclined from the bottom surfaceto the open surface toward the central portion of the groove 1220′, theside surface 1226 may also perform a function of the deviationpreventing means that prevents the contact-type patch stored in thegroove 1220′ from deviating to the outside instead of the deviationpreventing means.

In addition, a contact guiding means 1228 that facilitates contactbetween the contact-type patch stored in the groove and the specimen Ton the specimen plate 1400 may be provided at the bottom surface of thegroove.

FIGS. 19 and 20 are cross-sectional views of the storage unit in agroove form having various contact guiding means according to anembodiment of the present disclosure.

For example, the contact guiding means 1228 may be implemented as acontact guiding protrusion 1228′ that convexly protrudes from the bottomsurface 1224 of the groove 1220′ illustrated in FIG. 19. A portion ofthe contact-type patch stored in the storage unit 1220 protrudes fromthe inner surface of the patch plate 1200 by the contact guidingprotrusion, and accordingly, contact with the specimen T on the specimenplate 1400 may be facilitated. The contact guiding protrusion 1228′ doesnot always have to be in the form illustrated in FIG. 19, and, asillustrated in FIG. 20, the bottom surface 1224 of the groove 1220′itself may be formed as a convex surface 1228″ and serve as the contactguiding means 1228.

Although the storage unit 1220 has been described above as beingimplemented in a groove form, unlike this, the storage unit 1220 mayalso be in a hole form.

The hole may have a first open surface formed at the inner surface ofthe patch plate 1200, a second open surface formed at the outer surface,and a side surface. Here, a deviation preventing means for preventingthe contact-type patch stored in a direction of the second open surfacefrom deviating may be provided at the second open surface. For example,the deviation preventing means may be implemented as a deviationpreventing mesh.

Meanwhile, technical features (e.g., a size of an open surface, a depthof a groove, a deviation preventing step, a deviation preventingprotrusion, etc.) mentioned in the description of the storage unit 1220in a groove form may also be appropriately applied to the storage unit1220 in a hole form. For example, a diameter of the hole may be equal toor less than that of the contact-type patch, a length of the hole may beequal to or less than the thickness of the contact-type patch, or adeviation preventing protrusion may be formed on the side surface of thehole.

3.3. Structure of the Specimen Plate

FIG. 21 is a perspective view of an example of the specimen plate 1400according to an embodiment of the present disclosure. Referring to FIG.21, as described above, the specimen plate 1400 may have the disk-shapedbody 1402 having the inner surface 1404, the outer surface, and the sidesurface. The inner surface 1404 is a surface facing the patch plate 1200and may be provided in a circular shape in this embodiment.

A specimen area 1420 may be provided at a circular inner surface of thespecimen plate 1400. Here, the specimen area 1420 is an area in whichthe specimen T injected into the test kit 1000 is placed. Although thespecimen area 1420 may simply be an area into which the specimen T isinjected, the specimen area 1420 should be viewed as an area that evenincludes an area in which the specimen T is smeared when the specimen Tis smeared as in a blood smear examination. For example, when attemptingto perform a blood smear examination, blood may be injected in a form ofwater drops into the specimen area 1420 and then smeared.

The specimen area 1420 may be provided in a specific area of an innersurface of a body of the specimen plate 1400. For example, the innersurface in a predetermined angular range with respect to the center ofthe disk may be the specimen area 1420.

Although it will be described below, the specimen T placed in thespecimen area has to come into contact with the contact-type patchstored by the patch plate 1200 and has to be observed through anobservation hole. For this, the specimen area 1420 needs to be alignedwith each portion (the storage unit 1220, the observation hole, etc.) ofthe patch plate 1200 as the patch plate 1200 rotates relative to thespecimen plate 1400.

In addition, in consideration of a case in which a blood smearexamination is conducted using the test kit 1000, the specimen area 1420needs to provide an area sufficient for injected blood to be smeared.

In consideration of these points, the specimen area 1420 may be providedin an area of approximately 45 to 90° of the inner surface. The area maybe adjusted in consideration of the number of contact-type patchesstored in the patch plate 1200, whether a blood smear examination isperformed, etc.

Meanwhile, when a specimen is injected onto the specimen area 1420, thespecimen T may be directly dropped onto the specimen area 1420. Here, anincised portion of the patch plate 1200 may be aligned at the specimenarea 1420 so that the specimen area 1420 is exposed to the outside. Forthis, an angle range of the specimen area 1420 and an angle range of theincised portion of the patch plate 1200 may be adjusted to be equal toeach other.

In addition, a surface of the specimen area 1420 may be speciallytreated. For example, the surface of the specimen area 1420 may behydrophilic or hydrophobic. Specifically, the surface of the specimenarea 1420 may be coated to be hydrophilic or hydrophobic, or a portionof the specimen area 1420 of the specimen plate 1400 may be preparedwith a hydrophobic or hydrophilic material.

The specimen area 1420 is made to exhibit hydrophilia or hydrophobia inorder to 1) allow the specimen area 1420 to hold the injected specimen Tand/or 2) allow the specimen area 1420 to receive the staining sample140, the buffering solution B, etc. from the contact-type patch. Forexample, when attempting to perform a blood smear examination using theGiemsa staining technique, the specimen area 1420 may be provided to behydrophilic to hold injected blood and receive the Giemsa stainingsample 140 from the contact-type staining patch 100.

A remaining area of the inner surface of the specimen plate 1400 exceptthe specimen area 1420 may be a non-specimen area 1440. The non-specimenarea 1440 may be an area in which the specimen T is not expected to beinjected or smeared.

A surface of the non-specimen area 1440 may be treated to exhibit aproperty opposite from that of the surface of the specimen area 1420.For example, the non-specimen area 1440 may be hydrophobic when thespecimen area 1420 is hydrophilic, and conversely, the non-specimen area1440 may be hydrophilic when the specimen area 1420 is hydrophobic.

The non-specimen area 1440 is made to exhibit hydrophilia or hydrophobiain order to 1) inhibit the injected specimen T from being transferred tothe non-specimen area 1440 and/or 2) prevent the staining sample 140,the buffering solution B, etc. from being transferred from thecontact-type patch. Particularly, in a process in which the patch plate1200 is rotated relative to the specimen plate 1400 to bring thecontact-type patch into contact with the specimen T (even when a stepexists between the specimen area 1420 and the non-specimen area 1440),the contact-type patch may sweep and pass across the non-specimen area1440 of the specimen plate 1400. In this process, the staining sample140 or the buffering solution B may be unnecessarily wasted by beingtransferred to the non-specimen area 1440 from the contact-type patch,or the contact-type patch may be contaminated due to a foreign substanceon the non-specimen area 1440, and thus the non-specimen area 1440 istreated to be hydrophilic or hydrophobic to prevent the abovesituations. For example, when attempting to perform a blood smearexamination using the Giemsa staining technique, the non-specimen area1440 may be provided to be hydrophobic so that blood injected onto thespecimen area 1420 is not transferred thereto and/or the Giemsa stainingsample 140 is not transferred thereto from the contact-type stainingpatch 100.

FIG. 22 is a perspective view of an example of the specimen plate 1400with a step between the specimen area 1420 and the non-specimen area1440 according to an embodiment of the present disclosure.

Referring to FIG. 22, the non-specimen area 1440 may have a lower heightthan that of the specimen area 1420. For example, a step may be formedat a boundary between the specimen area 1420 and the non-specimen area1440. Thus, a distance between the inner surface of the patch plate 1200and the inner surface of the specimen plate 1400 corresponding to thenon-specimen area 1440 may be larger than a distance between the innersurface of the patch plate 1200 and the inner surface of the specimenplate 1400 corresponding to the specimen area 1420.

During a process in which the specimen T and the contact-type patch arebrought into contact with each other, the patch plate 1200 is rotatedrelative to the specimen plate 1400 so that the contact-type patch canbe aligned with the specimen area 1420. When there is a step between thespecimen area 1420 and the non-specimen area 1440, the contact-typepatch may be prevented from sweeping and passing across the non-specimenarea 1440 of the specimen plate 1400 during the rotation of the patchplate 1200 while the contact between the contact-type patch and thespecimen T on the specimen area 1420 is easily maintained. Accordingly,the staining sample 140 or the buffering solution B of the contact-typepatch may be prevented from being wasted due to being transferred to thenon-specimen area 1440 and contamination of the contact-type patch dueto contact with the non-specimen area 1440 may be inhibited.

3.4. Smearing Unit

Meanwhile, the test kit 1000 may further include a smearing unit 1240that smears the specimen T injected onto the specimen area 1420.Hereinafter, the smearing unit 1240 that smears the specimen will bedescribed.

In a conventional staining technique, smearing of the specimen T isperformed by a tester's manual work.

FIG. 23 is a view illustrating a blood smearing means according to theconventional blood smear examination process.

Referring to FIG. 23, in the conventional blood smear examinationprocess, the specimen T is first placed on the slide S and then anotherslide is brought into contact with the slide S on which the specimen Tis placed so that an acute angle is formed therebetween. Then, when atester slides the slide S on which the specimen T is placed while an endof the other slide remains in contact with the specimen T, the specimenT may be spread on the slide S and smeared. The angle between the slidesand a sliding speed need to be properly adjusted to smear the specimen Tin a desired form (e.g., a monolayer). Conventionally, there is aproblem of low stability due to the factors above totally depending onthe tester.

FIG. 24 is a cross-sectional view of the smearing unit 1240 of the testkit 1000 according to an embodiment of the present disclosure.

Referring to FIG. 24 in addition to FIGS. 15 to 17, the smearing unit1240 may be provided at any one side the incised portion of the patchplate 1200. The smearing unit 1240 may perform a function of smearingthe specimen T placed on the specimen area 1420.

The smearing unit 1240 may include an inclined surface 1242 that formsan acute angle with the inner surface of the specimen plate 1400 thatfaces the inclined surface 1242 when viewed from a side surface and asmearing film 1244 attached to the inclined surface 1242.

Hereinafter, a specimen smearing process using the smearing unit 1240will be briefly described. However, for convenience of description, thedescription will be given based on a blood smear.

FIG. 25 is a view illustrating a blood smearing process using thesmearing unit 1240 of the test kit 1000 according to the embodiment ofthe present disclosure.

First, as in (a) of FIG. 25, blood is injected onto the specimen area1420 of the specimen plate 1400. Here, the incised portion of the patchplate 1200 and the specimen area 1420 of the specimen plate 1400 arealigned with each other so that the specimen area 1420 is exposed to theoutside.

When the blood is injected, as in (b) of FIG. 25, the patch plate 1200is rotated with respect to the specimen plate 1400 (the direction ofthis rotation is defined as a “reverse direction”) so that the smearingunit 1240 is moved toward a spot into which blood is injected. As aresult, the smearing film 1244 and a blood drop placed on the specimenarea 1420 come into contact with each other.

When the smearing film 1244 and the blood come into contact with eachother, the blood spreads between the smearing film 1244 and the surfaceof the specimen area 1420 along the smearing film 1244 in a direction inwhich the patch plate 1200 is incised due to a capillary phenomenon.When the patch plate 1200 is a sector-shaped plate in which a disk iscut in the diameter direction, the blood spreads in the diameterdirection.

When the patch plate 1200 is rotated in a forward direction (opposite ofthe reverse direction) with respect to the specimen plate 1400 while theblood is spread, the blood may move along the smearing film 1244 and besmeared as illustrated in (c) of FIG. 25.

Here, the inclined surface of the smearing unit 1240 may preferably havean inclined angle of approximately 10 to 60° with respect to the innersurface of the specimen plate 1400. The size of the inclined angle maybe properly adjusted according to a property of the specimen T.

When the inclined angle is too large (e.g., a right angle), it may bedifficult for the capillary phenomenon to occur in a step in which thesmearing film 1244 and the specimen T come into contact with each other(the step illustrated in (b) of FIG. 25), and the specimen T may notsufficiently spread in the direction in which the patch plate 1200 isincised. In addition, even when attempting to smear the specimen T by aforward rotation, smearing may not be properly performed due to theblood not following the smearing film 1244.

On the other hand, when the inclined angle is too small, the capillaryphenomenon may not properly occur due to the smearing film 1244 and thespecimen T coming into contact with each other at a portion other than alower end portion of the smearing film 1244, and smearing may not beperformed due to the blood not properly following the smearing film1244.

A material that can be easily followed by the specimen T may be used forthe smearing film 1244. For example, when the specimen T is blood, ahydrophilic material should be used for the smearing film 1244 so thatthe blood is smeared by following the smearing film 1244 during theforward rotation of the patch plate 1200. When a hydrophobic smearingfilm 1244 is used for the specimen T which is blood, smearing may not beperformed.

When viewed from the top, the smearing film 1244 may be attached andinstalled along the direction in which the patch plate 1200 is incised.When viewed from the top, the smearing film 1244 should have a length ofan extent to which the specimen T can sufficiently spread according tothe capillary phenomenon in the direction in which the patch plate 1200is incised. For example, the smearing film 1244 may have a length ofabout 30 to 100% of an incised surface in the diameter direction.

When viewed from the side surface, the smearing film 1244 may beattached and installed at the inclined surface along the inclined anglethereof. Here, the smearing film 1244 is installed so it can touch theinner surface of the specimen plate 1400. Accordingly, the smearing film1244 may cause the capillary phenomenon at the specimen T.

Although it would be theoretically preferable that the lower end of thesmearing film 1244 be manufactured to accurately come into contact withthe inner surface of the specimen plate 1400, this is actuallyimpossible in consideration of manufacture tolerance and the like orhigh cost would be required.

Consequently, for the smearing film 1244 to come into contact with thespecimen area 1420, the smearing film 1244 may be installed in a way inwhich a lower portion thereof protrudes from the inner surface of thepatch plate 1200 in the direction of the inner surface of the specimenplate 1400. According to this, since the smearing film 1244 has somedegree of flexibility, the smearing film 1244 may come into contact withthe specimen area 1420 because the lower portion of the smearing film1244 is curled in a bent form. In addition to this, a groove may beformed at a lower portion of the inclined surface as a space in which acurled portion of the smearing film 1244 is accommodated.

Meanwhile, although it has been described above that the tester directlydrops the specimen T on the specimen area 1420 when the specimen T isbeing injected, unlike this, a loading unit 1250 through which thespecimen T is injected may also be provided.

FIG. 26 is a view illustrating the loading unit 1250 of the test kit1000 according to an embodiment of the present disclosure, and FIG. 27is a view related to loading of the specimen T using the loading unit1250 according to an embodiment of the present disclosure.

Referring to FIG. 26, the loading unit 1250 may include a pressing plate1252, a collecting pin 1254, and a loading hole 1256.

The pressing plate 1252 is a portion pressed by a testee's body partfrom which the specimen T will be collected. For example, whenattempting to collect blood from a person's fingertip, the pressingplate 1252 may be provided in the shape of a plate having a proper sizeto be pressed by the person's fingertip. The pressing plate 1252 may beinstalled at a position which enables the collected specimen T to betransferred to the specimen area 1420 of the specimen plate 1400. Forexample, the pressing plate 1252 may be disposed at an outer edgeportion of the incised surface of the patch plate 1200 or an outer edgeportion of the specimen area 1420.

The collecting pin 1254 is a pin installed to protrude from the pressingplate 1252. During a process in which the testee's body part presses thepressing plate 1252, the collecting pin 1254 pierces skin at the bodypart to allow the specimen T to be collected from the testee. Thecollecting pin 1254 may preferably be disposed at a central portion ofthe pressing plate 1252 and be installed toward an outer direction ofthe test kit 1000.

The loading hole 1256 is formed in the form of a hole that passesthrough the pressing plate 1252 and may be formed by passing from anouter surface (a surface coming into contact with the testee's bodypart) to the opposite surface thereof of the pressing plate 1252.Accordingly, the loading hole 1256 may load the specimen T from anoutside of the pressing plate 1252 to an inside of the test kit 1000,more specifically, toward the specimen area 1420 or the smearing unit1240 of the specimen plate 1400. The loading hole 1256 may be formednear the collecting pin 1254 and receive the specimen T collected fromthe testee's skin by the collecting pin 1254, and may transfer andinject the specimen T toward the specimen area 1420 or the smearing unit1240 according to the capillary phenomenon.

The loading of the specimen T may be performed as follows.

First, when a testee presses the pressing plate 1252 with a finger asillustrated in (b) of FIG. 27, blood comes out of skin of the finger bythe collecting pin 1254. As illustrated in (c) of FIG. 27, the blood istransferred through the loading hole 1256 to the outside of the specimenarea 1420 that comes into contact with the smearing film 1244. Thetransferred blood is transferred to the inside of the specimen area 1420by the capillary phenomenon between the smearing film 1244 and thespecimen area 1420. Then, the patch plate 1200 may be rotated in theforward direction with respect to the specimen plate 1400 to smear theblood.

When the loading unit 1250 is used in this way, the specimen T may beinjected into the test kit 1000 by only simply pressing the loading unitwith a testee's body part instead of a tester directly injecting thespecimen T into the specimen area 1420.

Meanwhile, the collecting pin 1254 may be omitted from the pressingplate 1252 in the process of loading the specimen T described above. Inthis case, as in (a) of FIG. 27, before the pressing plate 1252 ispressed using the testee's body part, a separate pin may be used toallow the specimen T to be collected from the corresponding body part.

3.5. Rotating and Lifting Operations of the Test Kit

It has been mentioned above that the process of staining the specimen Tcan be carried out by bringing the contact-type patch into contact withthe specimen T injected into the specimen plate 1400 while the patchplate 1200 rotates relative to the specimen plate 1400.

Specifically, a process of bringing the contact-type patch and thespecimen T into contact with each other may be carried out by 1)rotating the patch plate 1200 relative to the specimen plate 1400 toplace the contact-type patch on the specimen T or the specimen T whichis smeared; and 2) lowering patch plate 1200 relative to the specimenplate 1400 so that the contact-type patch stored in the patch plate 1200comes into contact with the specimen T.

The patch plate 1200 and the specimen plate 1400 are basically coupledin a way in which the inner surfaces thereof are spaced apart from eachother in a predetermined interval. This is to prevent the contact-typepatch stored in the patch plate 1200 from being swept by the specimenplate 1400 during a rotation process. Consequently, after thecontact-type patch is placed on the specimen T, the patch plate 1200 andthe specimen plate 1400 should be adhered to each other to bring thecontact-type patch into contact with the specimen T.

For this, lifting guides 1260 and 1460 may be formed at the patch plate1200 and/or the specimen plate 1400. The lifting guides 1260 and 1460may lift the patch plate 1200 and the specimen plate 1400 according torelative rotations of the patch plate 1200 and the specimen plate 1400.

FIG. 28 is a perspective view of the patch plate 1200 having the liftingguide 1260 according to an embodiment of the present disclosure, andFIG. 29 is a perspective view of the specimen plate 1400 having thelifting guides 1460 according to an embodiment of the presentdisclosure.

Referring to FIGS. 28 and 29, the lifting guides 1260 and 1460 may beformed at outsides of the bodies of the patch plate 1200 and thespecimen plate 1400. The lifting guides 1260 and 1460 formed at the twoplates may respectively include base plates 1262 and 1462 formed tosurround circumferences of the bodies and lifting patterns 1264 and 1464formed in predetermined patterns on the base plates 1262 and 1462.

The base plates 1262 and 1462 are formed to surround outercircumferential surfaces of the bodies of the patch plate 1200 and thespecimen plate 1400 with smaller thicknesses than the patch plate 1200and the specimen plate 1400. In other words, the base plates 1262 and1462 are bent with steps from circumferences of the inner surfaces ofthe patch plate 1200 and the specimen plate 1400 toward the outersurfaces thereof to form edges of the patch plate 1200 and the specimenplate 1400.

Meanwhile, in FIG. 28, a disk-shaped body may be used instead of theincised sector-shaped body for the patch plate 1200. In this case, thespecimen T may be transferred to the specimen plate 1400 through aspecimen injection hole 1230 instead of being dropped through theincised portion. In addition, although it has been described that thecoupling protrusion is formed at the patch plate 1200, a coupling holeinstead of the coupling protrusion may be formed in FIG. 28. Thecoupling hole communicates with a coupling hole at the specimen plate1400, and the two plates may be coupled to each other by a coupling pinfitted into a communication passage. Here, it should be noted that bothof the sector-shaped form and the disk-shaped body according to FIG. 28are modified examples not departing from the spirit of the presentdisclosure.

The lifting patterns 1264 and 1464 may be formed protruding or beingrecessed from the base plates. The lifting patterns 1264 and 1464 mayperform roles of adjusting an interval between the inner surfaces of thetwo plates according to relative angles between the two plates while thetwo plates are coupled to each other.

The lifting patterns 1264 and 1464 may each include a high point part H,a low point part L, a sloped part I, and a stepped part R. Here, thehigh point part H is the highest part of the lifting patterns 1264 and1464, and the low point part L is the lowest part of the liftingpatterns. For example, the high point part H may be a part thatprotrudes the most from the base plates, and the low point part L may bea part that does not protrude from the base plates. The sloped part Imay be a part with a slope that gradually increases from the low pointpart toward the high point part. The stepped part R may be a partperpendicularly bent from the high point part H toward the low pointpart L.

When the patch plate 1200 rotates with respect to the specimen plate1400, the patch plate 1200 may be lifted with respect to the specimenplate 1400 as the lifting pattern of the patch plate 1200 moves along anupper portion of the lifting pattern of the specimen plate 1400. Here,lifting refers to an interval between the two plates being narrowed orwidened. The patch plate 1200 moving away from the specimen plate 1400is defined as “ascending,” and the patch plate 1200 approaching thepatch plate 1400 is defined as “descending.”

A state in which the high point part of the specimen plate 1400 isaligned with the low point part of the other plate is a state in whichthe patch plate 1200 is maximally descended with respect to the specimenplate 1400, i.e. a state in which the interval between the two plates isminimal.

A state in which the high point part of the specimen plate 1400 isaligned with the high point part of the patch plate 1200 is a state inwhich the patch plate 1200 is maximally ascended with respect to thespecimen plate 1400, i.e. a state in which the interval between the twoplates is maximal.

In addition, while the high point part of the specimen plate 1400 movesfrom the low point part of the patch plate 1200 toward the high pointpart of the patch plate 1200 along the sloped part of the patch plate1200, the patch plate 1200 gradually ascends with respect to thespecimen plate 1400. Conversely, while the high point part of thespecimen plate 1400 moves from the high point part of the patch plate1200 toward the low point part of the patch plate 1200 along the slopedpart of the patch plate 1200, the patch plate 1200 gradually descendswith respect to the specimen plate 1400.

In addition, when the high point part of the specimen plate 1400 passesthe stepped part of the patch plate 1200 in a direction from the highpoint part of the patch plate 1200 toward the low point part of thepatch plate 1200, the patch plate 1200 perpendicularly descends withrespect to the specimen plate 1400.

Conversely, when the stepped part is formed at the patch plate 1200 andthe high point part of the specimen plate 1400 attempts to move in adirection from the low point part of the patch plate 1200 toward thehigh point part of the patch plate 1200, a rotation of the patch plate1200 relative to the specimen plate 1400 may be inhibited by the steppedpart.

The test kit 1000 may be designed in a way in which the contact-typepatch stored in the patch plate 1200 comes into contact with at least aportion of the inner surface of the specimen plate 1400 when the patchplate 1200 is maximally descended with respect to the specimen plate1400, and hereinafter, this is defined as a “contact state.” Forexample, in the contact state, the contact-type patch stored in thestorage unit 1220 may come into contact with the specimen T placed inthe specimen area 1420.

In addition, the test kit 1000 may be designed in a way in which thecontact-type patch stored in the patch plate 1200 does not come intocontact with the inner surface of the specimen plate 1400 at statesother than that in which the patch plate 1200 is maximally descendedwith respect to the specimen plate 1400, and hereinafter, this isdefined as a “separated state.” For example, in the separated state, thecontact-type patch stored in the storage unit 1220 may not come intocontact with the non-specimen area 1440.

In consideration of the principles above, the lifting patterns may bedesigned as follows.

The lifting patterns may be designed so that the contact state isreached at an angle at which the storage unit 1220 of the patch plate1200 is aligned with the specimen area 1420 of the specimen plate 1400.Accordingly, the contact-type patch stored in the storage unit 1220 maycome into contact with the specimen T.

In addition, the lifting patterns may be designed so that the contactstate is not reached at an angle at which the storage unit 1220 of thepatch plate 1200 is at an upper portion of the non-specimen area 1440 ofthe specimen plate 1400. Accordingly, the contact-type patch stored inthe storage unit 1220 may not come into contact with the non-specimenarea 1440.

Referring again to FIG. 29, the lifting pattern of the specimen plate1400 may be formed as follows.

The high point part is disposed at one or more portion of the edge ofthe specimen area 1420. Here, the portion may be the edge of thespecimen area 1420 at which the specimen is placed, or may be the edgeat a central point of an area in which the specimen T is smeared whenthe specimen T is smeared. The lifting pattern may be formed so that thelow point part is disposed at the edge of the non-specimen area 1440.The sloped part or the stepped part may be disposed between the highpoint part and the low point part.

Referring again to FIG. 28, the lifting pattern of the patch plate 1200may be formed as follows. FIG. 28 illustrates the patch plate 1200 in anouter surface direction.

The low point part is disposed at a portion of an edge of the storageunit 1220. Here, the portion may be an edge in the diameter directionfrom the center of the patch plate 1200 toward the center of the storageunit 1220. The high point part is disposed at remaining parts of theedge of the patch plate 1200. The sloped part or the stepped part may bedisposed between the high point part and the low point part.

According to the lifting patterns, the test kit 1000 may operate asfollows. First, the incised portion of the patch plate 1200 may bedisposed at an upper portion of the specimen area 1420 of the specimenplate 1400 such that the specimen area 1420 is exposed to the outside. Atester may directly drop the specimen T onto the exposed specimen area1420. When the specimen T is dropped, the patch plate 1200 is rotated inthe reverse direction with respect to the specimen plate 1400 to bringthe smearing unit 1240 into contact with the specimen T so that thespecimen T is spread along the smearing unit 1240. When the specimen Tis spread, the patch plate 1200 may be rotated in the forward directionto smear the specimen T. During this process, the high point part of thespecimen plate 1400 is in contact with the high point part of the patchplate 1200, and accordingly, the storage unit 1220 is not in contactwith the inner surface (the non-specimen area 1440) of the specimenplate 1400.

When the patch plate 1200 is further rotated in the forward directionafter the smearing is completed, the high point part of the specimenplate 1400 comes into contact with the low point part of the patch plate1200 disposed at the edge of the storage unit 1220, and accordingly, thetwo plates reach the contact state and the contact-type patch stored inthe storage unit 1220 comes into contact with the specimen T at thespecimen area 1420.

Here, the stepped part may be provided between the high point part atthe edge of the smearing unit 1240 and the low point part of the storageunit 1220. Accordingly, while passing through the stepped part, thepatch plate 1200 perpendicularly descends with respect to the specimenplate 1400, and thus the contact-type patch may come into contact withthe specimen T by being stamped thereon. In addition, after the stampingof the contact-type patch, a reverse rotation of the patch plate 1200may be inhibited by the stepped part.

When the patch plate 1200 is further rotated in the forward directionafter the stamping, the high point part of the specimen plate 1400passes the sloped part of the patch plate 1200. Accordingly, thecontact-type patch is separated from the specimen T as the patch plate1200 ascends from the specimen plate 1400.

The high point part of the specimen plate 1400 comes into contact withthe high point part of the patch plate 1200 again after passing thesloped part of the patch plate 1200, and the separation is completed.Accordingly, when the contact-type patch stored in the patch plate 1200passes an upper portion of the non-specimen area 1440, the contact-typepatch may not come into contact with the inner surface of the specimenplate 1400.

When there are one or more storage units 1220, the patch plate 1200 maybe further rotated in the forward direction. Here, the high point partof the specimen plate 1400 comes into contact with the low point part ofthe patch plate 1200 according to the next storage unit 1220, and thusthe next contact-type patch comes into contact with the specimen T. Thisprocess may be similarly followed by the stamping process and theprocess in which the contact-type patch is separated from the specimen Tby the sloped part described above.

When the patch plate 1200 is further rotated in the forward directionafter the specimen T is brought into contact with all contact-typepatches provided in the test kit 1000, the high point part of thespecimen plate 1400 comes into contact with the low point part formed atan edge of an observation unit of the patch plate 1200.

Here, the observation unit may be formed with an observation hole formedat one spot of the patch plate 1200, and the tester may observe andexamine the specimen T which is completely stained, and the like, usinga microscope, or the like.

According to the present disclosure, when staining a specimen, thespecimen is stained by only bringing a contact-type staining patch intocontact with the specimen instead of spraying a staining solution suchthat a staining process can become convenient.

In addition, according to the present disclosure, a pore in a gelreceptor of a contact-type staining patch stores a staining sample andinhibits external contamination or leakage such that staining can beperformed using a contact-type staining patch manufactured in advanceprior to staining at a desired time.

In addition, according to the present disclosure, a staining sample iswell-preserved in a gel receptor of a contact-type staining patch andonly a proper amount of the staining sample is transferred to a specimenwhen the contact-type staining patch comes into contact with thespecimen such that the contact-type staining patch can be used severaltimes and the waste of staining samples can be prevented.

In addition, according to the present disclosure, there is no residue ata specimen when a contact-type staining patch comes into contact withthe specimen such that a postprocessing process can be omitted.

In addition, according to the present disclosure, a contact-typestaining patch transfers a staining sample to a specimen using acontacting means instead of a conventional spraying means such thatstaining may also be performed without fixing the specimen.

In addition, according to the present disclosure, when staining aspecimen, various types of processes by which staining is accompaniedcan simply be performed by only bringing a contact-type stainingsupplementary patch into contact with the specimen such that an overallstaining process can become extremely simple.

In addition, according to the present disclosure, when a staining sampleis transferred to a specimen and then a buffering patch is brought intocontact therewith, an optimal pH of the staining sample is satisfiedsuch that staining performance can be improved. In addition, when thebuffering patch is used, an excess amount of buffering solution is nottransferred to the specimen such that there is almost no residue at thespecimen and a washing or drying process can be omitted.

In addition, according to the present disclosure, fixing, mordanting,and decolorizing by which a staining process is accompanied can beconveniently performed using a fixating patch, a mordanting patch, and adecolorizing patch.

Effects of the present disclosure are not limited to those mentionedabove, and unmentioned effects should be clearly understood by those ofordinary skill in the art to which the present disclosure pertains fromthe present specification and the accompanying drawings.

The description above is merely an illustrative description of thetechnical spirit of the present disclosure, and those of ordinary skillin the art to which the present disclosure pertains should be able tomodify and change the present disclosure in various ways within a scopenot departing from essential features of the present disclosure.Consequently, the embodiments of the present disclosure described abovemay also be implemented separate from each other or in combinations.

Consequently, the embodiments disclosed in the present disclosure arenot limiting to the technical spirit of the present disclosure butdescribe the same, and the scope of the technical spirit of the presentdisclosure is not limited by the embodiments. The scope of the presentdisclosure should be construed by the claims below, and all technicalideas within the scope equivalent with the claims should be construed asbelonging to the scope of the present disclosure.

What is claimed is:
 1. A specimen preparation kit for a diseasediagnosis comprising: a contact-type staining patch including a stainingsolution and a gel receptor, wherein the staining solution has adetection inducing substance configured to react with a specimen to beinspected; a patch storing member that supports and moves with thecontact-type staining patch; and a guide wall that guides the patchstoring member to move at least in a vertical direction, which isvertical to a plane on which the specimen is placed; wherein the patchstoring member is configured to be movably connected to a specimenreceiving member, wherein the patch storing member moves along the guidewall relative to the specimen receiving member in the verticaldirection.
 2. The specimen preparation kit of claim 1, wherein: when thepatch storing member is at a first position relative to a specimenreceiving member, the contact-type staining patch is in contact with thespecimen so that the staining solution is transferred to the specimenand when the patch storing member is at a second position relative tothe specimen receiving member, the contact-type staining patch isseparated from the specimen.
 3. The specimen preparation kit of claim 1,wherein: when the guide wall is connected with the specimen receivingmember, the guide wall is configured to not move in the verticaldirection relative to the specimen.
 4. The specimen preparation kit ofclaim 1, wherein: the patch storing member is configured to be directlyconnected to the specimen receiving member.
 5. The specimen preparationkit of claim 1, wherein: the guide wall is extended from the specimenreceiving member in a direction that is perpendicular to the plane. 6.The specimen preparation kit of claim 1, wherein: the guide wall isfixed to the specimen receiving member.
 7. The specimen preparation kitof claim 1, wherein: the detection inducing substance is configured tovisually label a target component in the specimen.
 8. The specimenpreparation kit of claim 1, wherein: the patch storing member contactswith an upper surface that is provided on the opposite side of a contactsurface that comes into contact with the specimen to support thecontact-type staining patch.
 9. The specimen preparation kit of claim 1,wherein: the contact-type staining patch is interposed between the planeand the patch storing member.
 10. The specimen preparation kit of claim1, wherein: the guide wall is spaced from the contact-type stainingpatch.
 11. The specimen preparation kit of claim 1, wherein: the guidewall includes a guide rail that is formed on the guide wall and providesa path for the patch storing member to move in the vertical directionrelative to the plane.
 12. The specimen preparation kit of claim 1,wherein: the patch storing member contacts with a side surface of thecontact-type staining patch, wherein the side surface is adjacent to acontact surface that comes into contact with the specimen of thecontact-type staining patch.
 13. The specimen preparation kit of claim1, wherein: the patch storing member covers an upper surface of thecontact-type staining patch on an opposite side of a contact surfacethat comes into contact with the specimen.
 14. A specimen preparationkit for a disease diagnosis comprising: a contact-type staining patchincluding a staining solution and a gel receptor, wherein the stainingsolution is configured to stain a specimen to be inspected placed on aspecimen receiving member; and a patch storing member which supports andmoves with the contact-type staining patch, wherein the patch storingmember contacts with the upper surface of the contact-type stainingpatch to support the contact-type staining patch, wherein the patchstoring member is configured to be movably connected to the specimenreceiving member, wherein the patch storing member further includes aguide formed on a side surface of the patch storing member and the guideis configured to guide the patch storing member to move relative to thespecimen receiving member.
 15. The specimen preparation kit of claim 14,wherein: the side surface of the patch storing member is not in contactwith the contact-type staining patch.
 16. The specimen preparation kitof claim 14, wherein: the guide guides the patch storing member to movein vertical direction relative to the specimen receiving member.
 17. Thespecimen preparation kit of claim 14, wherein: the guide guides thepatch storing member to move between a first position and a secondposition relative to the specimen receiving member, when the patchstoring member is at the first position, the contact-type staining patchis in contact with the specimen, and when the patch storing member is atthe second position, the contact-type staining patch is separated fromthe specimen.
 18. The specimen preparation kit of claim 14, wherein:when the patch storing member is at a first position relative to thespecimen, the contact-type staining patch is in contact with thespecimen so that the staining solution is provided to the specimen, andwhen the patch storing member is at a second position relative to thespecimen, the contact-type staining patch is separated from thespecimen.
 19. A specimen preparation kit for a disease diagnosiscomprising: a contact-type staining patch including a staining solutionand a gel receptor, wherein the staining solution has a detectioninducing substance configured to react with a specimen to be inspected;a patch storing member that supports and moves with the contact-typestaining patch wherein the patch storing member further includes a guideformed on a side surface of the patch storing member and the guide isconfigured to guide the patch storing member to move relative to thespecimen receiving member; and a guide wall that guides the patchstoring member to move at least in a vertical direction that is verticalto a plane on which the specimen is placed.